Periodontal probe

The periodontal probe addresses the challenge of diagnosing and treating periodontal diseases by capturing live images of pathogens in hard-to-reach areas, facilitating precise treatment planning and improving health outcomes.

WO2025212717A1PCT designated stage Publication Date: 2025-10-09SHAFFER LISA
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Patent Information

Application Number
PCT/US2025/022642
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-04-02
Filing Date
2025-04-02
Publication Date
2025-10-09

AI Technical Summary

Technical Problem

Existing technologies struggle to effectively diagnose and treat periodontal diseases caused by complex biofilms in the periodontal pocket and sulcus, which are difficult to access and require precise identification of pathogens for accurate diagnosis and treatment planning.

Method used

A periodontal probe with a narrow distal tip and integrated micrographic technology captures live images and data of periodontal pathogens, enabling precise measurement and recording of gum-tooth spaces to facilitate diagnosis and treatment planning.

Benefits of technology

Enables real-time visualization and analysis of biofilm colonization, allowing for targeted treatment protocols to disrupt and eliminate harmful pathogens, thereby improving oral and systemic health outcomes.

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Abstract

A periodontal probe is provided. The probe includes an elongate rod having a distal tip and a proximal handle portion. The distal tip is sufficiently narrow to be able to be inserted into a space between a patient's gum and tooth. The handle portion includes electronics configured to receive and transmit data obtained from the tip.
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Description

TITLE OF THE INVENTIONPERIODONTAL PROBEBACKGROUND OF THE INVENTION[OOO1] Field of the Invention

[0002] The present invention relates to the field of oral health conditions, identifying and capturing images of periodontal pathogens of bacterial and viral species for diagnostic purposes to identify, diagnose and evaluate for study and treatment for periodontal and systemic health related diseases.

[0003] Description of the Related Art

[0004] Over half of adults over age 30 and over 70% of adults 65 years of age have periodontal disease. Undiagnosed and untreated periodontal disease can lead to chronic periodontitis and loss of dentition and are related and attribute to many forms of systemic diseases. There are over approximately 700 bacterial species in which have been identified in the oral mucosa and oral cavity and nearly 350 species have been cultured and found to contribute to periodontal disease. Dental plaque is the precursor of periodontal disease and also promotes dental caries or dentinal decay. Dental plaque breaks down the enamel and dentinal surfaces and progresses into a degeneration of tooth structures and surrounding tissues which lead to oral and systemic infections. Periodontal pathogens found in the complex composition of dental plaque and formations of biofilms are forms of bacteria shown to significantly increase the risks of periodontal disease and oral decay which causes periodontitis and attributes to many progressions of oral and systemic degeneration.

[0005] In the awareness of over 700 periodontal pathogens and over 350 species and growing daily which have been cultured and identified existing in the structures of dental plaque there is a complex composition of bacteria, fungi, archaea, protozoa, and virus strains commonly known as bacteriophages and they consist of a substance referred to as biofilm. This complex composition most identified in the oral cavity is known to be a very aggressive and difficult to treat as a microorganism causing the diagnosis of periodontal disease and contributing to the degeneration of oral and systemic health conditions.

[0006] In order to diagnose and treat this complex composition of biofilm and periodontal pathogens found in the periodontal pocket and the base of the sulcus it is important to identify and capture the cellular composition in a very difficult to reach access point. This access point where the colonization of this complex biofilms is found is in the base of the sulcus of the periodontal pocket and at the base of the apex of the tooth and found in the surrounding oral soft tissues. It is often desired to capture a location point of where this colonization of biofilm is taking place and capture the characteristics to identify the exact periodontal pathogens causing the colonization leading to the degeneration of the subject's oral and potential disruption of future systemic health.

[0007] It would be beneficial to be able to provide a system that can measure and record information about the periodontal pocket and the base of the sulcus and base of the apex to enable the formulation of a diagnosis, prognosis and comprehensive treatment plan.SUMMARY OF THE INVENTION

[0008] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

[0009] In one embodiment, the present invention is a periodontal probe comprising an elongate rod having a distal tip and a proximal handle portion. The distal tip is sufficiently narrow to be able to be inserted into a space between a patient's gum and tooth.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings:

[0011] FIG. 1 is a schematic drawing of a system that uses a periodontal probe according to an exemplary embodiment of the present invention to record and measure gum / tooth information;

[0012] FIG. 1A is a side elevational view of the distal tip of the probe of FIG. 1, taken along circle 1A of FIG. 1;

[0013] FIG. 2A is a schematic drawing of the periodontal probe of FIG. 1 inserted into a gum line of a patient;

[0014] FIG. 2B is a schematic drawing of the probe of FIG. 2A advanced partially into the space between the gum and a tooth;

[0015] FIG. 2C is a schematic drawing of the probe of FIG. 2A fully inserted into the space between the gum and the tooth; and

[0016] FIG. 3 is a dental chart showing measurements of periodontal pockets using the probe of the present invention.DETAILED DESCRIPTION

[0017] In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The terminology includes the words specifically mentioned, derivatives thereof and words of similar import. The embodiments illustrated below are not intended to be exhaustive or to limit the invention to the precise form disclosed. These embodiments are chosen and described to best explain the principle of the invention and its application and practical use and to enable others skilled in the art to best utilize the invention.

[0018] Reference herein to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the invention. The appearances of the phrase "in one embodiment" in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of other embodiments. The same applies to the term "implementation."

[0019] As used in this application, the word "exemplary" is used herein to mean serving as an example, instance, or illustration. Any aspect or design describedherein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. Rather, use of the word exemplary is intended to present concepts in a concrete fashion.

[0020] The word "about" is used herein to include a value of + / - 10 percent of the numerical value modified by the word "about" and the word "generally" is used herein to mean "without regard to particulars or exceptions."

[0021] Additionally, the term "or" is intended to mean an inclusive "or" rather than an exclusive "or". That is, unless specified otherwise, or clear from context, "X employs A or B" is intended to mean any of the natural inclusive permutations. That is, if X employs A; X employs B; or X employs both A and B, then "X employs A or B" is satisfied under any of the foregoing instances. In addition, the articles "a" and "an" as used in this application and the appended claims should generally be construed to mean "one or more" unless specified otherwise or clear from context to be directed to a singular form.

[0022] Unless explicitly stated otherwise, each numerical value and range should be interpreted as being approximate as if the word "about" or "approximately" preceded the value of the value or range.

[0023] The use of figure numbers and / or figure reference labels in the claims is intended to identify one or more possible embodiments of the claimed subject matter in order to facilitate the interpretation of the claims. Such use is not to be construed as necessarily limiting the scope of those claims to the embodiments shown in the corresponding figures.

[0024] It should be understood that the steps of the exemplary methods set forth herein are not necessarily required to be performed in the order described, and the order of the steps of such methods should be understood to be merely exemplary. Likewise, additional steps may be included in such methods, and certain steps may be omitted or combined, in methods consistent with various embodiments of the present invention.

[0025] Although the elements in the following method claims, if any, are recited in a particular sequence with corresponding labeling, unless the claim recitations otherwise imply a particular sequence for implementing some or all of those elements, those elements are not necessarily intended to be limited to beingimplemented in that particular sequence.

[0026] Referring to the Figures, a periodontal probe 100 ("probe 100") is used to measure depths below a gum line and transmit the depth information to a remote location, such as a digital interface or a computer server 20, for processing. FIG. 1 provides a schematic drawing of probe 100 and other electronics for processing information provided by probe 100. Probe 100 takes periodontal gum depth measurements and transmits the measurements to a remote location.

[0027] Probe 100 is used to locate, measure, and diagnose issues in the gingival and subgingival region of a patient and to provide measurements for the design and fabrication of a dental tray that is specific to that patient.

[0028] To diagnose and treat this complex composition of biofilm and periodontal pathogens found in the periodontal pocket and the base of the sulcus it is desired to identify and capture the exact cellular composition with all existing properties in the exact site where the colonization is taking place. This can be a very difficult to reach access point in the periodontal pocket and surrounding oral soft tissues, as many anaerobic gram-negative biofilms submerge and colonize in areas where there is a lack of oxygen supply. This fundamental lack of oxygen supply enables the pathogens to not only survive but to thrive. This leads to the location of the base of the sulcus and surrounding oral tissues in a periodontal pocket becoming the perfect colonization environment for this biofilm to multiply and endure. This is exactly why it is desired to capture a location point of where this colonization of biofilm is taking place and capture the characteristics to identify the exact periodontal pathogens and their colonization formations that are causing the biofilm multiplications, thereby leading to the degeneration of the subject's oral health. This identification will enable the cellular structures to be captured in their colonization environment in live time with visual and viewable photographic documentation to capture and analyze. The complex biofilm structures of the microbic properties and microscopic components using probe 100 and its associated peripherals will capture the visibility of the anaerobic gram-negative biofilm in its current formation state and actuate the ability to identify and evaluate the images to immediate a course of action in a therapeutic approach to treat, disrupt and disable the further colonization of the complex structures which are contributing tothe degenerating effects of the oral structures.

[0029] Probe 100, with the integrated interface of micrograph or photomicrograph technology, can access the sulcus of the periodontal pocket, oral tissues and surrounding gingiva and capture a digital image taken through a micrographic component in the technology contained in probe 100. Probe 100 captures a lOOx digital microscopic image or a lOOx microscopic digital video of a colonization specimen in action, located at the base of a periodontal pocket and surrounding tissue structures in the periodontal pocket of the oral cavity. Probe 100 has the ability and capacity to identify existing colonizing biofilm or periodontal pathogens in its innate formation, in live time, multiplying and colonizing, causing degeneration of the periodontal structures and surrounding soft tissue structures contributing to periodontal disease, oral and systemic diseases and bacterial and viral infections.

[0030] A micrograph component in the technology of probe 100 contains a variety of extensive "live time" details of over 700+ microstructures. This data can be captured by a simple micrographic image or video of the colonizing anerobic structured material and can be analyzed, studied, and evaluated under several laboratorial specific conditions which can lead to new and unfounded discoveries and of the vulnerabilities of the colonized biofilms and develop new specifications of treatment protocols to disrupt, disable and eliminate the colonizing microscopic structures that lead to known and even unknown diseased states. This micrograph enabled probe 100 can evaluate the structured material under analysis in virtually unlimited separate conditions as the phases found in the grain size estimation stages of anerobic colonization, phases found in failure analysis, colonizing behavior systems and characteristics of elemental analysis of placebo effects of treatment and comparison in all data analysis combined.

[0031] Probe 100 is a narrow, elongate rod having a distal tip 110 and a proximal handle portion 150. Tip 100 is sufficiently narrow to be able to be inserted into a space between a patient's gum 50 and tooth 60, as shown in FIGS 2A-2C.Referring to FIG. 1A, distal most portion 112 of tip 110 houses a video camera 120 that provides live feed to a monitor 30 connected to server 20. Camera 120 is a microcamera with resolution to as low as 1,000 microns. Data recorded by camera120 includes, but is not limited to, gum condition, tooth root condition, and organic pathogens located in the space between gum 50 and tooth 60. Exemplary pathogens can include, but are not limited to, Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia (formerly known as Bacteroides forsythus), Treponema denticola, Fusobacterium nucleatum, Prevotella intermedia, Prevotella nigrescens, Eikenella corrodens, Eubacterium nodatum, Parvimonas micra (formerly known as Peptostreptococcus micros or Micromonas micros), Streptococcus intermedius.

[0032] The data recorded by camera 120 and sensors 114 can be transmitted to server 20 either by hard wire or radio frequency (RF), including, but not limited to, Blue Tooth® connections. Proximal handle portion 150 houses electronics and data capture and transmission components 152 for such data capture and transmission, as well as electrical power to operate various components of probe 100.

[0033] Distal tip 110 also includes a plurality of sensors 114 that sense pressure on distal tip 110 by gum 50 and tooth 60 pressing against sensor 114. Sensors 114 extend around the perimeter of distal tip 110 and are spaced a predetermined distance, such as 1 mm, apart from each other. In an exemplary embodiment, 10 sensors 114 can be provided, although those skilled in the art will recognize that more or less than 10 sensors 114 can be provided and that sensors 114 can be spaced more or less than 1 mm apart from each other.

[0034] Lights 116 are provided at various intervals along the outer periphery of distal tip 110. Lights 116 are provided both to provide light for camera 120, as well as to provide additional light for the clinician using probe 100. Lights can be fiber optic lights, LED lights, or other suitable lights for use at the distal tip 110.

[0035] The sensors 114 and lights obtain electrical power from handle 150. Sensors 114 also transmit sensed data to electronics and data capture and transmission components 152 for transmission to server 20.

[0036] The software used to process the data provided by probe 100 to server 50 is disclosed in U.S. Patent Application Serial No. 17 / 352,202, invented by the present inventor, the disclosure of which is incorporated herein by reference in its entirety.

[0037] Data provided by sensors 114 can be displayed on monitor 30 in the forma periodontal chart. An exemplary periodontal chart 125 is shown in FIG. 3 that shows subgingival pocket depths 130 in three locations for each of 32 teeth in a patient. The measured depths extend from 1 mm (tooth 2) to 5 mm (tooth 16). Additionally, graphic indicia 132 provides a visual representation of the depth of the subgingival pockets.

[0038] An explanation of the chart of FIG. 3 is provided below.

[0039] PERIODONTAL DEFINITIONS OF PERIODONTAL CHARTING:

[0040] PD: Pocket Depth

[0041] Pocket Depth is the most important variable for evaluating the health of a pocket (or deep sulcus). It is the apical displacement of the level of attachment that places the tooth in jeopardy not the increase in pocket depth, which may be due to coronal displacement of gingival margin.

[0042] -PD is measured in millimeters from the gum line.

[0043] -PD is assigned a value (1-19) based upon depth the probe reaches.

[0044] -PD is the most common measurement recorded.

[0045] -PD will display in color on the chart if it meets or exceeds the alert depth specified in exemplary dental practice management operating system with an easy- to-use interface with numerous digital integrations, including administrative, clinical, diagnostics, patient recording documentation, comprehensive accessible analytics and business operations capabilities. An exemplary operating system is Eaglesoft.

[0046] *CEJ: Cemento-Enamel Junction

[0047] The Cemento-Enamel Junction is the 'line' or 'border' where the enamel of the clinical crown meets the tooth.

[0048] GM: Gingival Margin

[0049] Gingival Margin is the area of the gingiva closest to the tooth surface, commonly referred to as the 'gum line'.

[0050] -GM reflects recession of the gum line.

[0051] -GM measures from the Cemento-Enamel Junction (CEJ).

[0052] -GM is assigned a positive value between 1-19 when the gum line is below the CEJ.

[0053] -GM is assigned a negative value of 1-10 when the gumline is above theCEJ.

[0054] CAL; CHmca Atachment

[0055] CAL is a calculation of Pocket Depth and Gingival Margin : CAL=PD+GM.

[0056] -The CAL rating reflects the overall risk of losing the tooth.

[0057] -The higher the CAL number, the greater the chance of losing the tooth.

[0058] MGJ: Mucogingival Junction

[0059] MGJ is the meeting of the thick, protective gingival tissue around the teeth and the friable mucous lining of the cheeks and lips.

[0060] -MGJ concerns the health of the area where the gum tissue and cheeks meet.

[0061] -MGJ is assigned a value between 1-9.

[0062] The clinical importance of the MGJ is in clinically measuring the attached gingiva. Defining the attached gingiva is an imperative diagnostic biometric tool for comprehensive periodontal exams determining health or diseased states. The clinical importance of the mucogingival junction is in measuring the width of attached gingiva. Attached gingiva is important because it is bound very tightly to the underlying alveolar bone and provides protection to the mucosa during functional use of the structures of the oral cavity during function, such as chewing. Without attached gingiva, the freely moveable alveolar mucosa, being more fragile, would suffer injury during eating and cleansing activities, such as brushing of the teeth.

[0063] The width of attached tissue is critical, because the more there is available provides a greater sense of protection against the aforementioned insults to the tissue. Using the mucogingival junction as the boundary demarcating the apical border of the attached gingiva, a periodontal probe is inserted into the gingival sulcus to measure how much of the keratinized gingiva coronal to the mucogingival junction is in fact attached to the underlying bone. The depth of the gingival sulcus, determined by the depth to which the probe enters the sulcus, is not attached to the underlying bone, and is subtracted from the total height of the keratinized tissue.

[0064] If the entire height of the keratinized gingiva, from the free gingival margin to the mucogingival junction is 8 mm, and the probing depth on the tooth atthat location is 2 mm, the effective width of attached gingiva is 6 mm.

[0065] If the probe enters the sulcus and can descend up to or beyond the mucogingival junction, this is called a mucogingival defect.

[0066] FG: Furcation Grade

[0067] FG is the amount of tissue destruction in areas on a multi-rooted tooth where the roots diverge.

[0068] -FG is measured if the gums have receded enough to expose the roots.

[0069] -FG cannot be measured on anterior teeth because they only have one root.

[0070] -FG is assigned grade ratings as follows:

[0071] 1 = Incipient bone loss.

[0072] 2 = Partial bone loss (cul-de-sac).

[0073] 3 = Total bone loss with through and through opening of furcation.

[0074] 4 = Grade 3 with gingival recession exposing the furcation to view.

[0075] The data numbers analyzed by the FG are vitally important to diagnosing defects and abnormalities and only multirooted teeth have furcation. Therefore, upper first premolar, maxillary and mandibular molars may be involved. Upper premolars have one buccal and one palatal root. Maxillary molars have three roots, a mesio-buccal root, disto-buccal root and a palatal root. Mandibular molars have one mesial and one distal root, and so.

[0076] Grade I furcation, scaling and polishing,15^ root surface debridement or furcationplasty could be done if suitable.

[0077] Grade II furcation, furcationplasty, open debridement, tunnel preparation, root resection, extraction, guided tissue regeneration (GTR or enamel matrix derivative could be considered.

[0078] Grade III furcation, open debridement, tunnel preparation, root resection, GTR., or tooth extraction could be performed if appropriate.

[0079] Tooth extraction is usually considered if there is extensive loss of attachment or if other treatments will not obtain good result (achieving a stabilized gingival contour to allow good plaque control).

[0080] Calculating and computing these diagnostic reports can determine what periodontal oral treatment is needed and what the prognosis of the tooth or teethwill be determined as a proper standard of care.

[0081] MOB: Mobility

[0082] MOB is the amount of mobility a tooth has within its socket, and one of the following ratings is assigned to each tooth.

[0083] 1 = Normal movement

[0084] 2 = Slightly to more than normal movement

[0085] 3 = Moderately to slightly

[0086] 4 = Severe mobility facial-1 ingually and / or mesiodistally, combined with vertical displacement.

[0087] There are a number of pathological diseases or changes that can result in tooth mobility. These include periodontal disease, periapical pathology, osteonecrosis and malignancies. Periodontal disease is the most commonly caused form of tooth mobility as a leading result caused by a build-up of plaque on the teeth which contain specific pathological bacterial biofilms and anaerobic forms of gram-negative microbes of bacteria. They produce an inflammatory response that has a negative effect on the bone and supporting tissues that hold your teeth in place. One of the effects of periodontal disease is that it causes bone resorption and damage to the supportive tissues. This then results in a loss of structures to hold the teeth firmly in place and they then become mobile. Treatment for periodontal disease can stop the progressive loss of supportive structures but it can not regrow to bone to make teeth stable again.

[0088] The treatment of tooth mobility depends on the etiology and the grade of mobility. The cause of mobility should be addressed to obtain an optimal treatment outcome and prognosis. When the tooth mobility is associated with periodontitis, periodontal treatment should be carried out immediately. In the presence of a periapical pathology, treatment options include drainage of abscess, endodontic treatment or extraction.

[0089] In use, distal tip 110 of probe 100 is inserted into a gumline between gum 50 and tooth 60 Distal tip 110 is gently inserted into the space between gum50 and tooth 60 until distal tip 110 can no longer be further advanced. Sensors 114 that have been advanced into the space sense pressure against sensors 114 by gum 50 and tooth 60 and transmit a force signal to server 20. Sensors 114 that have not yet been advanced into the gum line do not sense any force and do not transmit a force signal. If distal tip 110 is advanced, for example, a distance of 3 mm, then the three distal-most sensors 114 transmit their signal to server 20, and server 20 determines that distal tip 110 has been advanced 3 mm.

[0090] Server 20 then uploads the information from probe 100 to monitor 30 for display. Additionally, the data processed by server 20 is also forwarded to a dental tray manufacturer to fabricate a dental tray specific to the particular patient associated with cart 125 for use to administer medicament to the subgingival area of the patient's mouth, as is disclosed in U.S. Patent Application Serial No. 17 / 352,202.

[0091] After probe 100 measures and calculates all of the measurements shown in the locations in FIG. 3, calculates all of the biofilm present, and documents and records all of the data obtained, probe 100 then transfers all points of data, including pictures taken from camera 120, to a software interface program that can transfer all points of data directly to a 3D or CAD / CAM processor that is then used to fabricate a dental tray with the ports and cannulated passages down to the apex of the tooth directly from the data obtained by probe 100.

[0092] It will be further understood that various changes in the details, materials, and arrangements of the parts which have been described and illustrated in order to explain the nature of this invention may be made by those skilled in the art without departing from the scope of the invention as expressed in the following claims.

Claims

CLAIMSI claim :

1. A periodontal probe comprising: an elongate rod having a distal tip and a proximal handle portion, wherein the distal tip is sufficiently narrow to be able to be inserted into a space between a patient's gum and tooth.

2. The periodontal probe according to claim 1, wherein the distal tip houses a camera.

3. The periodontal probe according to claim 2, wherein the camera provides a live feed to a monitor.

4. The periodontal probe according to claim 3, wherein the video camera comprises a microcamera having a resolution to as low as 1,000 microns.

5. The periodontal probe according to claim 3, wherein data recorded by the camera includes gum condition, tooth root condition, and organic pathogens located in the space between the gum and the tooth.

6. The periodontal probe according to claim 5, wherein the pathogens include at least one pathogen selected from the list consisting of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Fusobacterium nucleatum, Prevotella intermedia, Prevotella nigrescens, Eikenella corrodens, Eubacterium nodatum, Parvimonas micra, and Streptococcus intermedius.

7. The periodontal probe according to claim 1, wherein the distal tip further comprises a plurality of sensors configured to sense pressure on the distal tip by the gum and the tooth pressing against at least one of the plurality of sensors.

8. The periodontal probe according to claim 7, wherein the sensors extend around a perimeter of the distal tip.

9. The periodontal probe according to claim 7, wherein each of the plurality of the sensors are spaced about 1 mm apart from each adjacent of the plurality of sensors.10.The periodontal probe according to claim 7, wherein the distal tip further comprises a plurality of lights located along the perimeter of the distal tip.The periodontal probe according to claim 14, wherein each of the plurality of lights is disposed between two of the plurality of sensors. The periodontal probe according to claim 1, further comprising software configured to process data provided by periodontal probe. The periodontal probe according to claim 12, wherein the data is displayed on the monitor as a periodontal chart. The periodontal probe according to claim 13, wherein graphic indicia on the periodontal chart provides a visual representation of a depth of subgingival pockets. The periodontal probe according to claim 1, wherein the proximal handle comprises electronics and data capture and transmission components for data capture and transmission. The periodontal probe according to claim 1, further comprising a software interface configured to transfer data to a processor, wherein the data is processed to fabricate a dental tray.

Citation Information

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