Method of operating a laser-assisted sterilization device and laser-assisted sterilization device

Abstract

To provide a dental implant device of a laser base for sterilizing and processing both a site and an implant before implant placement and after implant placement.SOLUTION: The BLAST Protocol is a tissue-sparing, tissue-integration, dental implant preparation, placement and maintenance protocol including use of a laser such as a free-running pulsed laser to irradiate the implant site before implant 260 placement, irradiate the implant or implant fixture before implant placement, and irradiate the surgical site once the implant is placed.SELECTED DRAWING: Figure 2I

Description

[Technical Field]

[0001] This application claims priority based on U.S. Provisional Patent Application No. 62 / 929,103, dated November 1, 2019, entitled “BLAST PROTOCOL”.

[0002] This application incorporates, as references, the full disclosures of U.S. Patent Applications No. 14 / 940,126, No. 15 / 011,441, and No. 15 / 257,656, entitled “Laser-Assisted Periodontics,” with Robert H. Gregg as inventor. This application incorporates, as references, the full disclosures of U.S. Provisional Patent Application No. 62 / 875,322, entitled “Laser-Assisted Periodontics And Tooth Extraction,” with Robert H. Gregg as inventor. This application incorporates, as references, the full disclosures of U.S. Patents No. 9,597,160 and No. 9,943,379.

[0003] The present invention relates to dental methods. In particular, the present invention relates to steps performed in connection with dental surgery, such as steps performed before, during, and after the placement of dental implants. [Overview of the project] [Problems that the invention aims to solve]

[0004] Laser-based tissue preservation, tissue integration, dental implant placement, and maintenance procedures are still in their early stages. [Means for solving the problem]

[0005] The BLAST protocol ("BLAST" or "Blast") is a protocol for tissue preservation, tissue integration, dental implant preparation, dental implant placement, and maintenance. BLAST is a laser-based oral implant treatment protocol.

[0006] In various embodiments, BLAST is designed to prepare the surgical site before, during, and after implant placement, enhance biocompatibility and increase the wettability of titanium implants, promote hemostasis, reduce inflammatory responses, activate and upregulate growth factors, stimulate osteoblast viability and proliferation, improve the stability of the bone-implant interface, shorten implant healing time, and achieve more predictable and successful long-term implant placement outcomes.

[0007] This protocol may be used in conjunction with immediate implant placement after tooth extraction or detachment when performing conventional implant procedures in healed edentulous areas. Parts of this protocol may also be used during routine tissue maintenance recalls to reduce the occurrence of peri-implant mucositis and peri-implantitis.

[0008] The blast may include methods and procedures comprising one or more of the following: angiogenesis, bone disinfection, fibrin, fibroblasts, growth factors, hemostasis, bone regeneration, bone reintegration, bone reintegration, selective photothermolysis, stem cells, and upregulation.

[0009] The effects of improving biocompatibility include improved adhesion to the surface of osteoblasts and multidirectional diffusion due to increased hydrophilicity (wettability) of titanium implants, improved corrosion resistance of titanium implants, contribution to improved biocompatibility of titanium implants and suppression of initial inflammatory events, improved fixation strength at the bone-implant interface, promotion of long-term bone integration and interface strength, formation of a titanium surface with high cell adhesion capacity, and improved bioactivity of the titanium surface.

[0010] The anti-inflammatory effects include blunting lipopolysaccharide-induced inflammatory responses, reducing immunological markers of inflammation in gingival crevicular fluid (interleukin-1 beta (IL-1β) and tumor necrosis factor (TNF-α)), reducing major collagenase species (interleukin-1 beta (IL-1β) and matrix metalloproteinase-8 (MMP-8)) in inflamed human periodontal tissue, and attenuating inflammatory responses by reducing lipopolysaccharide (LPS)-induced nitric oxide production and interleukin-8 production by endothelial cells.

[0011] Its bactericidal capabilities include the removal of biofilm and cleaning of contaminated implant surfaces, immediate suppression of red and orange composite periodontal bacteria below the culture detection limit in most deep periodontal pockets in humans, and excision of aerobic or anaerobic microbial species on implants without damaging the titanium surface.

[0012] The biostimulatory effects include stimulating the survival and proliferation of osteoblasts, inducing the expression of osteopontin, alkaline phosphatase, and Runt-related transcription factor 2 in osteoblasts, type I collagen in fibroblasts, and vinculin in endothelial cells, forming the basis of the molecular mechanisms that exhibit biostimulatory effects, stimulating bone regeneration by increasing osteoblast activity and promoting mineral deposition, increasing new bone formation, and shortening the implant treatment period by increasing bone interaction with hydroxyapatite-coated implants.

[0013] The present invention will be described with reference to the accompanying drawings. These drawings, incorporated herein and forming part of this specification, illustrate the invention together with the detailed description, illustrate the principles of the invention, and are further useful in enabling those skilled in the art to manufacture and use the invention. [Brief explanation of the drawing]

[0014] [Figure 1A]Figure 1A shows an exemplary table of some embodiments of the present invention. [Figure 1B] Figure 1B shows an exemplary table of some embodiments of the present invention. [Figure 2A] Figure 2A shows exemplary treatment steps of an embodiment of the present invention. [Figure 2B] Figure 2B shows exemplary treatment steps of an embodiment of the present invention. [Figure 2C] Figure 2C shows exemplary treatment steps of an embodiment of the present invention. [Figure 2D] Figure 2D shows exemplary treatment steps of an embodiment of the present invention. [Figure 2E] Figure 2E shows exemplary treatment steps of an embodiment of the present invention. [Figure 2F] Figure 2F shows exemplary treatment steps of an embodiment of the present invention. [Figure 2G] Figure 2G shows exemplary treatment steps of an embodiment of the present invention. [Figure 2H] Figure 2H shows exemplary treatment steps of an embodiment of the present invention. [Figure 2I] Figure 2I shows exemplary treatment steps of an embodiment of the present invention. **DETAILED DESCRIPTION OF THE INVENTION**

[0015] The BLAST protocol ("BLAST" or "blast") is a protocol for tissue preservation, tissue integration, dental implant preparation, dental implant implantation, and maintenance. BLAST aims to prepare the surgical site before, during, and after implant implantation, enhance biocompatibility and increase the wettability of titanium implants, promote hemostasis, attenuate the inflammatory response, suppress the production of inflammatory cytokines and prostaglandins, activate and upregulate growth factors, induce the expression of bone formation-related genes, stimulate the survival and proliferation of osteoblasts, improve the fixation of the bone-implant interface, shorten the implant healing period, and provide more predictable and more successful long-term implant implantation results. It is a laser-based oral implant treatment protocol.

[0016] This protocol may be used in conjunction with immediate implant placement when performing conventional implant treatment after tooth extraction or detachment, and in healed edentulous areas. Parts of this protocol may be used during routine tissue maintenance recalls to reduce the occurrence of peri-implant mucositis and peri-implantitis.

[0017] BLAST Figures 1A and 1B show tables relating dental implant scenarios to the relevant procedural steps of blast protocols that can be used to achieve each step. Generally, as seen in Figure 1A, tangled areas may accept implants immediately or soon after the intentional or accidental removal of a tooth or implant from that site. Alternatively, as seen in Figure 1B, untangled areas may accept implants some time after tooth removal and healing of the site.

[0018] Figure 1A summarizes the placement of implants after tooth extraction (intentional), tooth removal (accidental), or after the removal of previously placed implants. Implant maintenance will also be discussed below.

[0019] When implant placement occurs due to intentional, accidental, or replacement scenarios, the treatment steps aim to clean the implant site and alleviate conditions including bacterial LPS (lipopolysaccharide) contamination, NICO (neuroalgia-induced cavitation osteonecrosis) lesions, BRONJ (bisphosphonate-related osteonecrosis of the jaw), MRONJ (medication-related osteonecrosis of the jaw), and root resorption. In the case of implant replacement, the treatment steps may also include the removal of contaminated metal particles.

[0020] Embodiments of the blast protocol include treatment steps to cleanse and alleviate these conditions. For example, a blast protocol may include one or more of the following treatment steps in a given order or in a different order: 1. Incision is made in the soft tissue at the implant site. 2. Prepare the extraction site. 3. Perform the osteotomy using a sterilized carbide drill or bur. 4. Measure the depth of the osteotomy site. 5. Irradiate the prepared implant site with a laser. 6. The implant is irradiated with a laser (externally). 7. The implant is placed. 8. Perform biostimulation. 9. Perform maintenance treatment as needed.

[0021] Figure 1B summarizes the placement of implants in healed areas, such as sites that have healed after tooth extraction or implant removal. Implant maintenance will also be mentioned and discussed below.

[0022] Whether the placement of a new implant is for replacing a natural tooth or replacing an implant, the procedure aims to clean the implant site and alleviate conditions such as bacterial LPS (lipopolysaccharide) contamination, NICO (neuropathic cavitary osteonecrosis) lesions, BRONJ (bisphosphonate-related osteonecrosis of the jaw), MRONJ (drug-related osteonecrosis of the jaw), and root resorption. In the case of implant replacement, the procedure may also include the removal of contaminated metal particles.

[0023] Embodiments of the blast protocol include treatment steps to cleanse and alleviate these conditions. For example, a blast protocol may include one or more of the following treatment steps in a given or different order: 1. Incision is made in the soft tissue at the implant site. 2. Prepare the extraction site. 3. Perform the osteotomy using a sterilized carbide drill or bur. 4. Measure the depth of the osteotomy site. 5. Irradiate the implant site with a laser. 6. The implant is irradiated with a laser (externally). 7. The implant is placed. 8. Perform biostimulation. 9. Perform maintenance treatment as needed.

[0024] BLAST including the placement of new implants The BLAST procedure involves several steps related to the placement and / or maintenance of dental implants. For example, BLAST may address the placement of dental implants following accidental tooth loss, or the placement of dental implants in unobstructed sites. The following steps describe the BLAST procedure for implant placement.

[0025] Figure 2A is a plan view showing an intact portion of the oral cavity 200A of a human patient. Here, the natural dentition (dentition) 208 is fixed within the alveolar tori 209, where bone tissue (bone) is covered by intact soft tissue (mucosa) 204.

[0026] The empty (almost toothless) areas or spaces 205 between the teeth correspond to missing teeth, in this case, missing second premolars. Here, the edentulous areas are prepared to receive dental implants, for example, to replace missing teeth. After appropriate anesthesia is administered, a sterile surgical scalpel 202 is used to make an incision 206 in the mucosa 204 above to expose the underlying bone.

[0027] Figure 2B is a plan view of a disordered area in the oral cavity 200B of a human patient. Unlike Figure 2A, which includes an undisturbed area, here, tooth loss may be due to an accident involving the tissue surrounding the site of the missing second premolar in process 211. Tooth loss may be the result of traumatic detachment, extraction, or both.

[0028] In a first step (Step 1) which may include either a healing site or a subluxation site, the implant or osteotomy site 218 surrounded by gingival soft tissue 215 is surgically exposed by reflecting a gingival soft tissue flap 216. A sterile implant drill and / or bone bur 212 is prepared for use in forming an osteotomy site in the alveolar bone 209 to receive the dental implant (for example, for use in forming a socket or an enlarged socket). Bone graft material 214 may be inserted into the site as a condition guarantee to complement the patient's existing alveolar bone 209.

[0029] Figure 2C shows the preparation of the osteotomy site in the patient's jaw 200C. In the second step (step 2), the osteotomy is performed using a sterile implant drill and / or bur 222, which may be of various dimensions to properly prepare for receiving a specific or various size implant. At the implant placement site 218, bone tissue is removed from the alveolar bone 209, so bone is removed or a cavity 217 is formed. A pilot hole 223 may be formed, and then the osteotomy site is formed, which is a cavity of bone volume represented by a gray vertical cylinder 224 (see Figure 2D) within the alveolar tori.

[0030] Figure 2D shows measurements of the osteotomy site created in the patient's jaw 200D. In the third step (step 3), the full depth "d" of the osteotomy site 224 is measured at specific points using a sterile periodontal probe 232. For example, three or more measurements may be taken. For example, the measurements may be equally spaced or unevenly spaced, and may be taken at the deepest position or the shallowest position. In some embodiments, this procedure ensures that the prepared site is free of obstructions and / or of appropriate depth to allow for the subsequent insertion of a specific dental implant, such as a second premolar implant of a particular size.

[0031] Figure 2E shows the preparation for laser irradiation of the osteotomy site and its surrounding area 200E. Here, the laser includes, for example, a laser orientation system having a handpiece 241, a laser fiber 242 extending from the handpiece, and a cannula enclosing a portion of the extending laser fiber. The fiber terminates with a free length "l" extending from the cannula.

[0032] In the fourth step (step 4), the free length of the laser fiber 242 is positioned close to the prepared implant site 218. The optical fiber is for transmitting laser energy to the implant site 218, as controlled by the clinician. The free length of the laser fiber 242 is adjusted using the above measurements to allow access to and / or energy transmission to a specific depth, such as the maximum depth of the osteotomy site 224. In various embodiments, the laser beam is not activated before insertion into the osteotomy site.

[0033] Figure 2F shows the use of a laser to irradiate the osteotomy site and its surrounding area 200F. In the fifth step (step 5), a flexible optical fiber with a free length 242 is inserted to the full depth 254 of the osteotomy site 224, and then the laser beam is activated by the clinician 252. The laser beam may be activated when the fiber is withdrawn from the site.

[0034] Hemostasis is initiated by the heat generated by the pulsed laser beam. The process of inserting the free length 242 into the osteotomy site 224 and removing the free length from the osteotomy site may be repeated until the desired amount of hemostasis or hemostatic state is achieved. This process may simultaneously result in one or more of the following: activation of growth factors present in the blood, upregulation expression of bone formation-related genes to stimulate osteoblast viability and proliferation, and inhibition of inflammatory cytokine and prostaglandin production to shorten the implant healing period.

[0035] Figure 2G shows extracorporeal laser irradiation preceding implant insertion 200G. In the sixth step (step 6), the sterile titanium dental implant 260 is irradiated 266 before insertion into the osteotomy site 224. The implant may be held by forceps 262 near the dental implant platform 267 and may be used to rotate the implant 264. It should be noted that in some embodiments, the dental implant may be made from one or more materials, such as metals, which may or may not contain titanium.

[0036] In some embodiments, the entire surface of the implant below the contact cylinder 261 is irradiated with a pulsed laser beam via an attached optical fiber. The optical fiber may be held so as not to come into contact with the implant surface. This procedure enhances the hydrophilic (wettability) properties of the implant and increases the adhesion and multidirectional spread of osteoblasts along the implant surface, thereby improving the fixation of the bone-implant interface.

[0037] Figure 2H shows implant 200H ready for implantation. In the seventh step (step 7), the irradiated implant 260 is positioned in close proximity 272 to the osteotomy site 224 of the alveolar bone tori 209. Bone graft material 214 may be inserted at the site to ensure that the patient's existing alveolar bone 209 is supplemented.

[0038] Figure 2I shows the implant and biostimulator 200I inserted into the osteotomy site. In the eighth step (step 8), the irradiated implant 260 is inserted 284 to an appropriate depth within the osteotomy site 224.

[0039] After the implant 260 is inserted into the osteotomy site 224, the clinician activates a laser beam from both the facial and lingual surfaces toward the implant 260 and / or surrounding area 203, with the free end of the optical fiber 242 remaining in contact with the surrounding tissue. Here, the emitted laser / light energy penetrates the adjacent tissue. In various embodiments, the results may include one or more laser-induced biostimuli that stimulate bone regeneration by increasing osteoblast activity, promoting mineral deposition, and shortening the healing period of soft tissue and bone tissue at the implant site, thereby providing more predictable and successful long-term implant placement outcomes.

[0040] BLAST including peri-implantitis of existing implants Infections and inflammation around dental implants are caused by certain bacteria found in plaque and tartar (calculus). These bacteria produce toxins that irritate the gums, creating deep pockets and destroying bone attachment to the implant. Over time, these toxins destroy gum tissue, worsen the infection, and can even lead to bone loss.

[0041] Therefore, minimally invasive surgical methods are needed for the removal of deep pockets, the elimination of disease, the reattachment of gingiva to the implant surface, and the reintegration of the implant with the bone.

[0042] Accordingly, according to one exemplary embodiment described herein, a dental disease associated with a dental implant is treated. The average power of the laser is selected by a user interface on a display, along with a set of acceptable laser parameters provided in correspondence with the selected average power. A gingival sulcus or flap is formed around the implant with the laser. Infected tissue is selectively excised or degenerated by selective photothermolysis, creating a pocket around the infected implant. Steps are taken to remove corrosive products and promote and maintain angiogenesis. The surrounding tissue is pressed against the implant to eliminate occlusal interference.

[0043] This configuration typically allows for the treatment of implant mucositis and peri-implantitis while reducing pocket loss around the implant, attaching new connective tissue to the implant at or near the coronal level, and reintegrating the implant with the bone.

[0044] In one embodiment, the selection of the average power of the laser is received via a user interface on a display device, and a set of acceptable laser parameters is provided to the display device and the laser head in response to the selected average power. The laser head is controlled according to the laser parameters to form a gingival sulcus or flap around the implant, excise or denature infected tissue via selective photothermolysis, and irradiate the pocket around the infected tissue with the laser.

[0045] In yet another embodiment, excision or degeneration of infected tissue includes excision or degeneration of inflamed, infected, erythematous, edematous, hyperplastic, ulcerated, degenerated, bleeding, suppurating, or flaked periodontal or peri-implant soft tissue, including sulcus epithelium, junctional epithelium, and keratinized tissue, via selective photothermal dissolution.

[0046] The laser device is a handheld laser for performing laser treatments, including laser dental treatments (e.g., excision of bacteria in gum tissue, reduction of contamination of dental implants). The exemplary laser may be integrated into the handpiece, or the handpiece may extend from the laser device via a fiber optic umbilical. For example, the laser may correspond to the "Perioreze® MVP-7®" manufactured by Millennium Dental Technologies, Inc. In this regard, the Perioreze® MVP-7® is a 6-watt FR (self-propelled) Nd:YAG (neodymium:yttrium aluminum garnet) laser with the necessary features for performing soft tissue treatments, and includes, for example, operator-selectable pulse durations of 100 to 650 microseconds (μs) to enable optimal excision and hemostasis.

[0047] Peri-implant infections, inflammations, and peri-implant diseases are caused by certain bacteria in plaque and tartar (calculus). These bacteria produce toxins that irritate the gums, resulting in the destruction of bone attachment to the implant. Over time, these toxins destroy gum tissue, the infection progresses, and bone loss can occur. There are various types of peri-implant diseases, but the most common are peri-implant mucositis and peri-implantitis. Peri-implant mucositis is in its earliest stages and affects only the periodontal tissue. At this stage, the disease is still reversible.

[0048] However, if left untreated, peri-implant mucositis can progress to a more serious condition called peri-implantitis. The gums, bone, and other structures supporting the implant become damaged. The implant may become loose and need to be removed. At this stage, more complex treatment may be required to prevent implant loss. With healthy gums (periodontal tissue), the implant is firmly fixed to the bone. Peri-implant mucositis develops when toxins in plaque irritate the gums, causing them to become red, soft, swollen, and prone to bleeding. Peri-implantitis occurs when these toxins destroy tissue and bone. The gums detach from the implant, pockets form, and these pockets become filled with plaque. As the implant loses bone, peri-implantitis progresses. If left untreated, the implant in the affected area may frequently loosen and fall out.

[0049] Traditionally, the first step in treating peri-implantitis has been a thorough cleaning, including scaling to remove plaque and tartar below the gum line. If deep pockets of 4-6 mm or more are found, surgery may be necessary. It is difficult for dentists and dental hygienists to completely remove plaque and tartar from deep pockets. Furthermore, patients are rarely able to remove plaque and keep their teeth clean. Leaving pockets untreated can lead to infection and bone destruction.

[0050] If the pocket is deep and bone is destroyed, it may be necessary to perform flap surgery to access the surface of the implant, thoroughly remove tartar, plaque, and diseased tissue, and reshape the bone into a more favorable structure. This method involves lifting the gum and returning it to its original position, or suturing it to a new position for easier cleaning.

[0051] Traditionally, after excising a soft tissue flap, crushed tissue and granulation tissue were removed from the implant surface. Aesthetically improved versions of this method have been reported under names such as open flap curettage, reverse blade flap surgery, Widmann flap surgery and modified Widmann flap surgery, apical gingival flap repositioning, and guided tissue regeneration.

[0052] Nevertheless, conventional methods lack adequate minimally invasive surgical techniques for reducing deep pockets, eliminating disease, reattaching gingiva to the implant surface, and reintegrating implants with bone. Exemplary embodiments to address these problems are described below.

[0053] BLAST, including laser-based implant maintenance treatment for existing peri-implant disease Treating peri-implant mucositis and peri-implantitis may involve reducing early, shallow, and deep bone pockets and removing pathological tissue, peri-implant pathogens, pathological proteins, calculus and other deposits on the implant surface, and corrosive byproducts of metal implant degradation. This allows for the regrowth, regeneration, and reintegration of new bone into the implant. Notwithstanding the above, it should be noted that not all implants are made of titanium (e.g., ceramic), and this process may apply to other types of implants as well.

[0054] The process may include forming a gingival sulcus or flap around the implant with a contact laser fiber (after removing the prosthetic crown first, if possible), and selectively excising or denature the infected and inflamed pocket epithelium via selective photothermolysis. This process may further include vaporizing or denature the medial marginal gingival tissue and pocket epithelium and granulation tissue all around the target implant to an accessible depth of the defect without penetrating soft tissue attachments above the depth of the bone defect; ultrasonically removing necrotic tissue from the implant surface; moving to the full depth of the bone defect via blunt dissection through any soft tissue attachments and perforating the bone defect; correcting the bone by osteoplasia and / or osteoctomy below the mucoperiosteal level as needed; creating angiogenesis; lasering the pocket to disinfect and decontaminate the soft and hard tissues and the implant; assisting hemostasis; cauterizing free nerve endings; sealing lymphatic vessels; preparing coronal soft tissue to approach the implant; and compressing the soft marginal tissue against the implant until blood flow is stopped, adhesion is achieved, and a stable fibrin mass is formed. In one example, the removal of traumatic occlusal forces is typically achieved by removal of the implant-retained restoration or, if removal is not an option, by occlusal adjustment.

[0055] This configuration allows for the treatment of peri-implant mucositis and peri-implantitis pocket defects by establishing new connective tissue attachment to the implant, typically at or near the coronal level. Furthermore, the inflamed pocket epithelium is usually selectively separated via photothermolysis without substantially removing the connective tissue.

[0056] In this regard, locally placed anesthetics are used to numb the area. For example, a dentist may begin with 4% prilocaine plain using a 30-gauge needle. This anesthetic is perceived as painless by the patient due to its unique ability to numb soft tissue without puncture. The anesthetic is injected very slowly into the affected area, and it takes several minutes for the prilocaine plain to take effect. The dentist can then continue the procedure using a 30-gauge needle and an appropriate anesthetic that has a longer-lasting effect, with the exception of cases where anesthetics are contraindicated for health reasons. This treatment typically uses one to three implant anchors and can be combined with the LANAP® protocol to treat two quadrants or one arch, either upper or lower. In all treatments, anesthesia is used with the aim of accurately measuring the depth of the affected pocket and bone defect using bone sounding as described later, actively removing soft and hard tissue from the implant surface, ensuring the patient is as comfortable as possible during treatment, thereby minimizing the secretion of endogenous adrenaline, ultimately achieving optimal treatment results, allowing the physician to concentrate their abilities to the fullest extent on the treatment, and making optimal use of ultrasound probes with frequencies from 1 Hz to 50,000 Hz.

[0057] As another preliminary step, a periodontal probe can be used to record the depth of all bone defects in the soft tissue surrounding the implant, up to the extent of bone defects accessible from the supragingival margin, and bone sounding and pocket depth measurement can be performed. In one example, pocket depth can be recorded using a periodontal probe that records six areas around each implant. This allows for a complete understanding of the depth of pathological pockets. The dentist can use the sum of the depths of the six probes / bone sounding and multiply that number by 4 to calculate the "radiation dose" of 4 / joules per millimeter of pocket depth (for example, with six probes at depths of 10 mm each, the total radiation dose would be 60 mm × 4 = 240 joules). The sum of the probe depths represents the total amount of joules irradiated. The total radiation dose is supplied by laser irradiation in the first step of LAPIP® excision (2 / 3) and the remaining 1 / 3 by laser irradiation in the second step of LAPIP® hemostasis setup (in the example above, 160 joules are irradiated during the LAPIP® excision step and joules are irradiated during the LAPIP® hemostasis step). In this way, radiation dose calculations are performed in conjunction with the surgical treatment.

[0058] Excision is performed. In this regard, laser energy excision of the free gingival margin removes pathogens and pathological proteins in the free margin tissue that cannot be removed otherwise, while laser irradiation of the implant surface is used, for example, to remove only granulomatous tissue, intentionally leaving disinfected granulation tissue, for disinfection of pocket tissue surface, hemostasis assistance, cauterization of free nerve endings, and sealing of lymphatic vessels.

[0059] Cleaning is performed, for example, with an ultrasonic handpiece, in conjunction with further cleaning using a laser orientation system. In particular, the implant surface is cleaned from all foreign matter to the full depth of the pocket on all sides of the implant, from the stigmatism margin to the bone base. For example, the dentist uses an ultrasonic handpiece to ultrasonically scale the entire implant surface down to the depth of the pocket, with the intention of removing all foreign structures and materials (including calcium and cement) from the implant surface, thereby enabling the bonding of laser-irradiated soft tissue to the clean implant surface. Osteotomy and / or bone modification by osteotomy may also be performed. Next, a laser orientation system may be used for deep periodontal pockets with a laser fiber output power of 1 to 6 watts and a frequency of 1 to 100 Hz for optimal bacterial destruction without causing bacterial injection into the periodontal tissue. This minimizes the occurrence of soft tissue cellulitis.

[0060] A laser alignment system allows for laser irradiation to remove only granulation tissue, intentionally leaving disinfected granulation tissue behind. This enables disinfection of the pocket tissue surface, hemostasis assistance, cauterization of free nerve endings, sealing of lymphatic vessels, and preparation for adhesion of the pocket tissue surface. The laser irradiation device may also be used to stop blood flow as needed.

[0061] In one specific example, but not limited to this disclosure, the laser orientation system may consist of a feed of FiberFlex® 360-micron diameter quartz optical fiber passing through a handpiece such as an anodized aluminum True-Flex® handpiece and an annealed stainless steel cannula. The dentist activates the laser and intentionally irradiates the bone at the base of the bone defect at six separate pocket depth measurement locations to initiate hemostasis from the medullary bone, stimulate and upregulate the release of growth factors (e.g., IGF-I and IGF-II, TGF-β1, TGF-β2, BMP-2), stimulate and control fibroblasts and stem cells, warm the blood in the pocket to thermally cleave fibrinogen, thereby converting the blood into fibrin, the body's first connective tissue (thrombin catalyzes the conversion from fibrinogen to fibrin), create a stable fibrin mass, create angiogenesis (new angiogenesis), intentionally remove and / or denature any remaining, residual granulation tissue, and inflamed, infected, and diseased endothelial layer, while intentionally leaving granulation tissue (stalk cells, capillaries, fibroblasts) in place, for example, cauterize free nerve endings on the pocket tissue surface, seal lymphatic vessels, and prepare the pocket tissue surface for adhesion.

[0062] This procedure is classified into surgical flap treatment and "laser cyst regeneration," and occlusal adjustment may be limited or complete. In some cases, when crown removal is not involved, 20 minutes is a reasonable time to treat a single implant-supported device. As suggested above, post-treatment procedures include crown polishing / prevention, follow-up for occlusal balance, and post-operative checks of the treated area.

[0063] In yet another exemplary embodiment, excision or degeneration of infected tissue includes excision or degeneration of inflamed, infected, erythematous, edematous, hyperplastic, ulcerated, degenerated, bleeding, suppurating, or flaking periodontal or peri-implant soft tissue, including sulcus epithelium, junctional epithelium, and keratinized tissue, via selective photothermal decomposition.

[0064] Next, a further exemplary aspect of one embodiment of the exemplary procedure will be described. In one embodiment, the area of ​​concern, usually two quadrants, is anesthetized. The procedure is applied independently to each implant involved. The depth of the pocket is measured and recorded using a perioprobe to determine the full depth of the pathological pocket. A contact laser fiber is irradiated along the longitudinal axis of the implant to excise the gingival margin and epithelium within the pocket, forming a gingival sulcus or flap and exposing the implant surface. By appropriately cutting the contact laser fiber, precise control of the laser energy, the physical distribution of the laser energy, and the desired physical direction of the laser to the tissue to be removed can be determined. The implant surface is exposed and visualized using the gingival sulcus or flap. By excising the gingival margin, pathogens and pathological proteins in the unresectable tissue are removed, hemostasis is achieved, and visualization is facilitated. In this step, the integrity of the mucosa is maintained by defining the tissue margins and relieving tissue tension before using mechanical instruments. Also, the separation between the free gingival margin and the fibrous collagen matrix that anchors the gingiva is released. This allows the gingival margin ridge to be maintained. The hot-tip effect allows for further excision of the epithelium within the pocket surrounding the implant to the depth read by the probe. Normally, the optical fiber is not used to penetrate the mucogingival junction. The hot-tip effect (accumulation of tissue proteins heated by secondary conduction of laser energy as it passes through the fiber) allows for selective removal of grooved and pocket epithelium and granulation tissue circumferentially and radially, without substantially removing connective tissue. If necessary, the excised tissue accumulated at the tip of the laser fiber is removed. The implant surface is ultrasonically scaled to the depth of the pocket. The aim is to remove foreign matter within the pocket and enable adhesion between the soft tissue and the clean implant surface. Laser irradiation is performed to remove granulation tissue within the pocket, disinfect the tissue, control bleeding, cauterize nerve endings, seal lymphatic vessels, and prepare for adhesion of soft tissue and fibrin mass to the implant surface.

[0065] The removal of occlusal interference is completed, for example, using the high-speed handpiece described herein. This step is useful for obtaining the best results, as it allows tissue healing and bone regeneration. The laser reshapes the tissue so that new attachment can occur, but if the trauma of malocclusion continues, the tissue cannot withstand it and begins to break down immediately. All treatment sites are irrigated to the deepest part of the periodontal pocket with a tissue-sparing bactericidal solution (e.g., chlorhexidine gluconate 0.12%). This irrigation reduces bacteria in the pocket and assists the laser in removing debris. Approach to the wound margin is completed. Further laser irradiation is performed as needed to control blood flow. Healing of the wound margin is secondary. Apply pressure to the implant from the facial and lingual sides for 1-3 minutes to allow a thin thrombus to form between the tissue and the implant.

[0066] Postoperatively, medications for home use are prescribed, and postoperative care is reviewed with the patient. An occlusal splint, such as the "QuickSplint®," or an anterior "jig" can be used to guide the occlusion forward. Thorough follow-up examinations of occlusal adjustment are necessary. This treatment must be continued regularly until bone growth is complete. Pocket depth measurements should be avoided for 12 months.

[0067] In another exemplary embodiment, laser-assisted peri-implant mucositis and peri-implantitis bone regeneration and bone reintegration treatment uses a self-propelled pulsed neodymium:yttrium-aluminum-garnet laser apparatus with a wavelength of 1,064 nanometers, a duty cycle of 0.2–1.3 percent (100–650 microseconds at 20 Hz), an average power output of 3.0 watts, 150 millijoules, a peak power output of 1500 watts / pulse, and an energy density of 147 J / cm². 2 Power density 2947 watts / cm² 2 ~Average output 3.6 watts, average output 150 millijoules, power density 2947 watts / cm² 2 6 watts, 180 millijoules, peak output 1800 watts / pulse, energy density 177 J / cm² 2 Power density 3537 watts / cm²2 Preferably use the self-propelled pulsed Nd:YAG PerioLase (registered trademark) MVP-7 (trademark) to anesthetize the mucosal gingival tissue corresponding to the patient's target implant. The implant has an implant surface, and bone sounding uses a periodontal probe. Record the depth of all bone defects in the soft tissue at six sites around the implant and up to the bone, from the upper gingival margin to the extent of the bone defect accessible. Record the sum of the six probe depths / bone soundings and multiply by a pre-specified constant (in this example, 4). (It represents a "light dose" of 4 joules per 1 millimeter of pocket depth. Example: Six probes with a depth of 10 mm each = 60 mm × 4 = 240 joules of total light dose).

[0068] The total light dose is set such that most of the total light dose is irradiated during the first-stage laser irradiation of the LAPIP (trademark) resection, and the remaining part of the total light dose is irradiated during the second-stage laser irradiation of the LAPIP (trademark) hemostasis setting. In this example, two-thirds of the total light dose is applied during the first-stage laser irradiation of the LAPIP (trademark) resection, and the remaining one-third of the energy is supplied during the second-stage laser irradiation with the LAPIP (trademark) hemostasis setting. In this example, 160 joules are irradiated in the LAPIP (trademark) resection step, and 80 joules are irradiated in the LAPIP (trademark) hemostasis step. In this procedure, further, an average output of 3.0 - 3.6 watts, a repetition frequency of 20 hertz, a pulse time of 100 microseconds, and a duty cycle of 0.2 percent are used. The average power in watts, 150 millijoules, a peak power of 1500 watts / pulse, 147 J / cm 2 of energy density, 2947 watts / cm 2 from the power density result in an average power of 3.6 watts, 180 millijoules, a peak power of 1800 watts / pulse, 177 J / cm 2 of energy density, 3537 watts / cm 2 of power density.

[0069] In this embodiment, a TrueFlex® handpiece made of anodized aluminum and FiberFlex® quartz optical fibers with diameters of 300, 320, 360, and 400 microns (preferably 360 microns) are further used to excise, denature, and vaporize granulomatous tissue, inflammation, infection, and ulcerated intraepithelium in the pocket. Hard, calcified calculi and stones on the implant surface are photothermally altered, broken, denatured, dehydrated, and destroyed, and a new coronal apex surface for connective tissue adhesion and osseointegration is prepared in the soft tissue area of ​​the pocket across the entire surface of the implant. This example includes irradiating the implant surface with a laser to destroy lipopolysaccharide (LPS) of Gram-negative bacteria, preferential use of a LANAP® piezoelectric ultrasonic device having a "P" tip, "Ball" tip, and "PS" tip operating at 20,000 to 30,000 Hz and 8 to 10 watts, cleaning the implant surface to remove foreign matter, calcium, and cement from the entire depth of the pocket from the apex of the implant to the bottom of the bone defect, detaching the apex and marginal bone to perform osteotomy and / or osteoctomy and initiate angiogenesis, irrigating the pocket with a bactericidal solution, preferably 0.12% chlorhexidine, and using a laser with an average output of 3.0 to 4.0 watts, a repetition frequency of 20 Hz, a pulse duration of 150 to 650 microseconds, and preferably a duty cycle between 0.3% and 1.3%. For a pulse duration of 150 microseconds, the average power is 3.0 watts, 150 millijoules, peak power is 1000 watts / pulse, and energy density is 147 J / cm². 2 Power density 2947 watts / cm² 2 With a duty cycle of 0.3 percent, an average power of 4.0 watts, 180 millijoules, a peak power of 1333 watts / pulse, and an energy density of 196 J / cm². 2 Power density 3930 watts / cm² 2 With a duty cycle of 0.3 percent and pulse durations up to 650 microseconds, it boasts an average power of 3.0 watts, 150 millijoules, a peak power of 231 watts / pulse, and an energy density of 147 J / cm². 2Power density 2947 watts / cm² 2 Duty cycle from 1.3 percent, average power 4.0 watts, 180 millijoules, peak power 307 watts / pulse, energy density 196 J / cm² 2 Power density 3930 watts / cm² 2 Duty cycle of 1.3 percent.

[0070] In one embodiment, the procedure further involves using 300, 320, 360, and 400 micron (preferably 360 micron) diameter FiberFlex® quartz optical fibers supplied through an anodized aluminum TrueFlex® handpiece and an annealed stainless steel cannula; intentionally irradiating the bone defect base with a laser at six separate pocket depth measurement positions to initiate hemostasis from the medullary bone; stimulating and upregulating the release of growth factors (e.g., IGF-1 and IGF-II, TGF-β1, TGF-β2, BMP-2); stimulating and upregulating fibroblasts and stem cells; thermally cleaving fibrinogen, thereby converting blood into fibrin. To convert (thrombin catalyzes the conversion of fibrinogen to fibrin), to create a stable fibrin clot, to warm the blood in the pocket to create angiogenesis, to disinfect, remove and / or denature any remaining, residual granulation tissue and the endothelial layer of inflammation, infection and disease, intentionally leaving granulation tissue (stem cells, capillaries, fibroblasts), to disinfect the pocket tissue surface, to aid hemostasis, to cauterize free nerve endings and occlude lymphatic vessels, to prepare the pocket tissue surface for adhesion, to irradiate the pocket tissue surface with a laser to adapt to tissue adhesion, with an average power of 3.0 watts, 150 millijoules, a peak power of 1000 watts / pulse, and an energy density of 147 J / cm². 2 Power density 2947 watts / cm² 2 From there, it has an average power of 4.0 watts, 180 millijoules, a peak power of 1333 watts / pulse, and an energy density of 196 J / cm². 2 Power density 3930 watts / cm²2 This includes bringing the pocket tissue surface and the implant surface closer together, maintaining contact between the pocket tissue surface and the implant surface to promote bonding, and eliminating occlusal interference.

[0071] In one embodiment, depth measurement is completed with a periodontal probe, measuring at least six intervals around the implant. In another embodiment, excision, evaporation, and laser irradiation are performed with a laser fiber oriented parallel to the surface of the implant.

[0072] In yet another embodiment, the procedure includes the step of providing a self-propelled pulsed Nd:YAG, 1064 nanometer wavelength laser, preferably PerioLase® MVP-7®, where the excision, degeneration, and vaporization are completed by a laser with an average power output of 6.00 watts or less and a laser frequency of 100 Hz or less, as measured at the distal end of the fiber. (Average power output 3.0 watts, 150 millijoules, peak power 1500 watts / pulse, energy density 147 J / cm²) 2 Power density 2947 watts / cm² 2 From there, the average output is 3.6 watts, 180 millijoules, peak output is 1800 watts / pulse, and energy density is 177 J / cm². 2 Power density 3537 watts / cm² 2 .

[0073] In yet another embodiment, the laser fiber has a diameter between approximately 200 and 600 microns. In yet another embodiment, the method involves applying firm pressure to hold the pocket tissue surface in contact with the implant surface for 1 to 3 minutes in order to form a thin mass between the pocket tissue surface and the implant surface.

[0074] In some embodiments, laser-assisted peri-implant mucositis and peri-implantitis bone regeneration and bone reintegration treatments utilize a self-propelled (FR) pulsed neodymium:yttrium-aluminum-garnet (Nd:YAG) laser device with a wavelength of 1,064 nanometers, comprising a duty cycle of 0.2–1.3% (preferably 100–650 microseconds, less than 100 Hz, preferably 20 Hz), with an average power of less than 10 watts, preferably 3.0–3.6 watts, between 150 and 180 millijoules, peak power between 231 watts / pulse and 1800 watts / pulse, and 147 J / cm². 2 and 177 J / cm 2 The energy density between and 2947 watts / cm². 2 and 3537 watts / cm² 2It operates over a suitable parameter range, including power densities between [values]. The procedure involves a) anesthetizing the mucogingival tissue corresponding to the target implant in the patient, with the implant having an implant surface; b) performing bone sounding in the pocket around the target implant using a periodontal probe, recording the depth of all bone defects at six sites from the supragingival margin to the extent of bone defect accessible from the soft tissue and bone around the implant; c) recording the sum of all six probe depths / bone sounding and multiplying by 4 to obtain a total ray dose estimate in joules to be distributed; and d) excising, denature, and vaporizing disease, inflammation, infection, ulcerated epithelium, implant corrosion products, and granulation tissue within the pocket to photothermally alter and destroy hard calcified calculus and tartar on the implant surface in the soft tissue area of ​​the pocket on both sides of the implant in order to prepare a new, coronal connective tissue and bone reintegration surface, wherein the excision, denature, and vaporization steps involve applying 2 / 3 of the estimated total ray dose using a quartz optical fiber with a small diameter of 400 microns or less, via a handpiece and annealed stainless steel cannula, within preferred parameters, FR The following steps are performed while operating an Nd:YAG laser device: e) laser irradiation of the implant surface to destroy and denature the lipopolysaccharide (LPS) of Gram-negative bacteria; f) cleaning all foreign matter, calcium, and cement from the implant surface to the full depth of the pocket on all sides from the crestal margin to the bone defect base, where the cleaning step includes water washing and the application of a laser and / or preferably a piezoelectric ultrasonic device with appropriate tip operation at 20,000 to 30,000 Hz and 8 to 10 watts; g) detaching the apical and marginal ridges of bone to perform osteotomy and / or osteotomy and to initiate angiogenesis; h) preferably chlorhexidine 0.i) Perfusing the pocket with a 12% sterilizing solution, intentionally irradiating the base of the bone defect with a laser at six separate pocket depth measurement locations to initiate hemostasis from the medullary bone, stimulating and upregulating the release of growth factors (e.g., IGF-1 and IGF-II, TGF-β1, TGF-β2, BMP-2), stimulating and upregulating fibroblasts and stem cells, thermally cleaving fibrinogen, thereby converting blood into fibrin (thrombin catalyzes the conversion of fibrinogen to fibrin), and stabilizing the fibrin j) creating a brin clot, creating angiogenesis, warming the blood in the pocket, disinfecting and removing and / or degenerating any remaining, residual granulation tissue and inflammatory, infected, and diseased endothelial layer, intentionally leaving granulation tissue (stem cells, capillaries, fibroblasts), disinfecting the pocket tissue surface, assisting hemostasis, cauterizing free nerve endings and sealing lymphatic vessels, and preparing the pocket tissue surface for adhesion, j) irradiating the pocket tissue surface with a laser to adapt the pocket tissue surface for tissue adhesion, where the laser irradiation in steps i) and j) is FR The Nd:YAG laser device is operated within preferred parameters of 3.0–4.0 (not 3.6) average power and a duty cycle of 150 (not 100)–650 microseconds at 20 Hz, while applying the remaining 1 / 3 of the total estimated light dose using a small-diameter quartz optical fiber supplied through a handpiece and annealed stainless steel cannula; including k) bringing the pocket tissue surface close to the implant surface, l) maintaining contact between the pocket tissue surface and the implant surface to promote adhesion, and m) eliminating occlusal interference.

[0075] The pocket depth may also be measured using a periodontal probe around the implant, where a predetermined constant may be used so that the estimate of the total ray dose transmitted in joules is obtained by multiplying the total millimeters of probe depth / bone sounding by a predetermined constant.

[0076] The above method may include laser irradiation to intentionally irradiate the bone at the base of the bone defect, the laser irradiation step further stimulating and upregulating the release of growth factors, and stimulating and upregulating fibroblasts and stem cells.

[0077] The above method can be used to kill or inactivate bacteria, spores, fungi, viruses, and bacteriophages by simultaneously, sequentially, or individually irradiating tissue with blue light-emitting devices that emit wavelengths in the range of 400-520 nm (e.g., 405, 420, 425, 470 nm), such as laser diodes, titanium-sapphire lasers, argon ion lasers, light-emitting diodes, superluminescent diodes, halogens, plasma arc curing (PAC), or other light sources, thereby inhibiting biofilm formation.

[0078] In one embodiment, the illumination from the blue light-emitting device is coaxial with the aiming light used to guide the laser. In another example, the blue light-emitting device includes a separate energy source and a separate handpiece from those of the laser. Thus, the blue light-emitting device can be combined with the hardware that constitutes the laser or operate completely independently.

[0079] In some embodiments, the procedure is controlled to perform a step of circumferential and radial irradiation of the implant surface to denature or excavate bioactive bacterial products, including lipopolysaccharide endotoxin. According to another exemplary embodiment, the laser irradiation is performed circumferentially and radially to remove corrosion byproducts of the titanium oral implant, including corroded soluble fragments, metal oxides, particulate fragments, and metal ions resulting from metal dissolution in diseased soft tissue. In yet another embodiment, the laser irradiation is performed circumferentially and radially on the titanium implant surface and threads to denature or excavate bioactive bacterial products, including lipopolysaccharide endotoxin.

[0080] Laser-assisted gingival margin resection removes pathogens and pathological proteins from the tissue of the gingival margin that cannot be resected. Laser irradiation of the implant surface can destroy lipopolysaccharide (LPS) of Gram-negative bacteria. Furthermore, this method provides hemostasis for better visualization and further defines the tissue margin preceding piezo-electric instruments. Additionally, by relaxing the tension of the tissue around the implant prior to mechanical manipulation, the separation between the free gingival margin and the fibrous collagen matrix that anchors the gingiva is eliminated, maintaining mucosal integrity. Healing of the fibrous collagen matrix allows the gingival margin apex to be maintained at the same level as before the procedure, thus enabling gingival margin preservation.

[0081] A quartz optical fiber directed at an angle of 30 degrees or less relative to the implant surface can be used to irradiate the implant surface with a laser to destroy lipopolysaccharide (LPS). An angle greater than 30 degrees is dangerous because the Nd:YAG laser pulses may interact with the implant surface. A few pulses of Nd:YAG laser energy will not damage terminally ill, diseased, or malfunctioning implants if irradiation is stopped immediately to prevent heat buildup within the implant. A "bare" quartz optical fiber has a beam divergence angle of 27 degrees. Therefore, even if parallel to the implant surface, the Nd:YAG laser light can reach the surface through "side-reflection" scattering.

[0082] Although various embodiments of the present invention have been described above, it should be understood that these are presented only as examples and are not limiting. It will be apparent to those skilled in the art that various modifications in form and detail can be made without departing from the spirit and aspects of the present invention. Thus, the breadth and scope of the present invention should not be limited by the exemplary embodiments described above, but should be defined only in accordance with the following claims and their equivalents.

Claims

1. A method for operating a laser-assisted sterilization device for disinfecting and treating both the osteotomy site and the dental titanium implant fixation device before and after the implantation of the dental titanium implant fixation device at the osteotomy site, wherein the device is A handpiece with a cannula, A laser fiber extending from the cannula of the handpiece, A pulsed laser beam generator, The display and Control device and Equipped with, The laser fiber extends from the tip of the cannula and has a length that matches the maximum depth of the osteotomy site. The aforementioned method, The control device includes the step of displaying one or more laser operating parameters for the pulsed laser beam to be output from the pulsed laser beam generator on the user interface on the display in a selectable manner, Before implantation, when the laser fiber has been inserted to the maximum depth of the osteotomy site, the control device causes the pulsed laser beam generator to irradiate a pulsed laser beam from the tip of the laser fiber according to one or more selected laser operating parameters, Before implantation, the control device performs the step of irradiating the pulsed laser beam generator with the pulsed laser beam over the entire surface of the dental titanium implant fixation device, After implantation, the control device irradiates the pulsed laser beam generator with the pulsed laser beam directed towards the dental titanium implant fixation device within the osteotomy site, A method for providing this.

2. The method according to claim 1, characterized in that the step of irradiating the dental titanium implant fixator is performed to protect the patient from infection and reduce inflammation.

3. The method according to claim 1, characterized in that the one or more laser operating parameters are a set of selected laser operating parameters.

4. The method according to claim 1, characterized in that the step of irradiating the entire surface of the dental titanium implant fixator is performed in order to obtain a hydrophilic implant surface of the dental titanium implant fixator.

5. The method according to claim 1, characterized in that the step of irradiating the entire surface of the dental titanium implant fixation device is performed by a pulsed laser beam with an average power of 10 watts or less.

6. The method according to claim 5, characterized in that the diameter of the laser fiber is between 200 microns and 600 microns.

7. The method according to claim 1, characterized in that the step of irradiating the tip of the laser fiber with a pulsed laser beam according to one or more selected laser operating parameters is performed before implantation in order to initiate the formation of a stable fibrin thrombus.

8. The method according to claim 1, characterized in that the wavelength of the pulsed laser beam is 1064 nm.

9. A laser-assisted sterilization device for disinfecting and treating both the osteotomy site and the dental titanium implant fixation device before and after the implantation of the dental titanium implant fixation device at the osteotomy site, A handpiece with a cannula, A laser fiber extending from the cannula of the handpiece, A pulsed laser beam generator, The display and Control device and Equipped with, The laser fiber extends from the tip of the cannula and has a length that matches the maximum depth of the osteotomy site. One or more laser operating parameters for the pulsed laser beam to be output from the pulsed laser beam generator are selectively displayed on the user interface on the display. The control device causes the pulsed laser beam generator to irradiate the tip of the laser fiber with a pulsed laser beam that conforms to one or more selected operating parameters before implantation, and the pulsed laser beam is a laser beam that irradiates the osteotomy site. The pulsed laser beam is a laser beam used to irradiate the dental titanium implant fixator in order to obtain a hydrophilic implant surface of the dental titanium implant fixator before implantation. After implantation, the pulsed laser beam is a laser beam that biologically stimulates the region including the osteotomy site. A laser-assisted sterilization device characterized by the following features.

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