Clinical trial NCT05932017: Comparison of Gingival Flap Procedure Using Conventional Surgical Loupes vs. Videoscope for Visualization
Official title: Comparison of Gingival Flap Procedure Using Conventional Surgical Loupes vs. Videoscope for Visualization. A Pilot Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Periodontal Diseases
Periodontal Pocket
Periodontitis
Periodontal Inflammation
Periodontal Attachment Loss
Periodontal Bone Loss
Surgery
Keywords: videoscope
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be identified at the Texas A\&M University dental school clinic.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Probing Depth (in millimeters)
timeFrame: baseline
measure: Clinical Attachment Level (in millimeters)
timeFrame: baseline
measure: Bleeding on Probing (yes or no)
timeFrame: baseline
measure: Probing Depth (in millimeters)
timeFrame: These will be collected at 3 months post-surgery.
measure: Clinical Attachment Level (in millimeters)
timeFrame: These will be collected at 3 months post-surgery.
measure: Bleeding on Probing
timeFrame: These will be collected at 3 months post-surgery.
measure: Probing Depth (in millimeters)
timeFrame: These will be collected at 6 months post-surgery.
measure: Clinical Attachment Level (in millimeters)
timeFrame: These will be collected at 6 months post-surgery.
measure: Bleeding on Probing
timeFrame: These will be collected at 6 months post-surgery.
measure: Probing Depths (in millimeters)
timeFrame: These will be collected at 1 year post-surgery.
measure: Clinical Attachment Level (in millimeters)
timeFrame: These will be collected at 1 year post-surgery.
measure: Bleeding on Probing
timeFrame: These will be collected at 1 year post-surgery.
Secondary outcomes:
measure: Bacterial Species Identification
timeFrame: These will be collected at the initial visit
measure: Bacterial Species Identification
timeFrame: These will be collected at 3 months post-surgery.
measure: Bacterial Species Identification
timeFrame: These will be collected at 6 months post-surgery.
measure: Bacterial Species Identification
timeFrame: These will be collected at 1 year post-surgery.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas A&M University School of Dentistry
state: Texas
Study officials:
affiliation: Texas A&M University
name: Carlos Parra Carrasquer, DDS
role: PRINCIPAL_INVESTIGATOR
References: