Comparison of Gingival Flap Procedure Using Conventional Surgical Loupes vs. Videoscope for Visualization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-03-31

Brief Summary

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This study is being performed to compare different methods of visualization during routine gum surgery. The gum surgery is standard of care. This study will compare the use of a small camera (videoscope) in conjunction with magnification glasses during surgery vs. surgery only using magnification glasses. Both methods are routinely used and are standard of care methods of visualization. The small camera (videoscope) is a device which allows us to see the area under high magnification and projects live video feed on a computer screen.

The study is a split-mouth design pilot study. The patients are only receiving treatment that was previously diagnosed prior to entering the study. The treatment performed is standard treatment that fits in the routine standard of care. No interventional treatment is being performed. The only difference is the method of visualization/observation by the practitioner used during the surgical procedure. One side of the mouth will be treated with just loupes while the other side of the mouth will be treated with loupes and the videoscope.

Detailed Description

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It is well known that tartar makes at-home oral hygiene care more difficult. The plaque and bacteria that accumulate on tartar are considered the primary factors contributing to gum disease. Conventional gum surgery is commonly performed using loupes (magnification glasses). The use of a videoscope, a handheld miniature camera, allows for greater visualization during surgery. While the debris on the root surface of teeth is not visible with loupes, it is easily observed when the root surface is visualized with the high magnification of the videoscope. The videoscope allows for up to 40x magnification to visualize underneath the gumline. The use of loupes and the videoscope are methods of visualization that are standard of care at the Texas A\&M College of Dentistry.

This study is being performed to compare different methods of visualization during routine gum surgery. The gum surgery is standard of care. This study will compare the use of the videoscope in conjunction with loupes during surgery vs. surgery only using loupes. No aspect of this study is investigational, however, bacterial samples will be collected from the patients at multiple time points to assess outcomes. The collection of bacterial samples for research will be conducted through paper points and an oral rinse. These methods are well-established methods of data collection.

Data will be sent to OralDNA labs for analysis. A special contract is required between the school and the company as they will be paid for the services rendered.

Hypothesis: Does the use of the videoscope in conjunction with loupes, as compared to only using loupes for visualization during surgery, have a positive effect (i.e. reduced inflammation and active disease) on the outcomes of gum surgery.

Conditions

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Periodontal Diseases Periodontal Pocket Periodontitis Periodontal Inflammation Periodontal Attachment Loss Periodontal Bone Loss Surgery

Keywords

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videoscope

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients receiving routine, pre-diagnosed, standard of care procedures.

Single cohort of patients receiving previously prescribed treatment. The only variable will be the modality of visualization utilized on each side of the mouth during the surgical procedure.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients that are treatment planned for open flap debridement in two or more quadrants
* age \>18 years old
* Stage III periodontitis diagnosis
* Probing depths ≥5mm with bleeding on probing

Exclusion Criteria

* systemic disease affecting bone metabolism
* current smokers
* diabetes
* pregnant women
* adults unable to consent
* prisoners
* previous or current bisphosphonate use
* recent joint replacement requiring prophylactic antibiotics
* teeth that necessitate and undergo osseous recontouring (shaping of the bone) will be excluded

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos Parra Carrasquer, DDS

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University

Locations

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Texas A&M University School of Dentistry

Dallas, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB2022-1044

Identifier Type: -

Identifier Source: org_study_id