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

NCT05932017 | Enrolling By Invitation

• 1 other identifier: IRB2022-1044
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

videoscope

Outcome Measures

Primary Outcomes (12)

• Probing Depth (in millimeters)

  The distance from the soft tissue (gingiva or alveolar mucosa) margin to the tip of the periodontal probe during usual periodontal diagnostic probing. The health of the attachment apparatus can affect the measurement. (Definition from the American Academy of Periodontology Glossary of Periodontal Terms). The instrument used to measure the probing depth is the periodontal probe. The periodontal is a calibrated probe used to measure the depth and determine the configuration of a periodontal pocket. (Definition from the American Academy of Periodontology Glossary of Periodontal Terms).

  baseline

• Clinical Attachment Level (in millimeters)

  The distance from the cemento-enamel junction to the tip of the periodontal probe during usual periodontal diagnostic probing. The health of the attachment apparatus can affect the measurement. (Definition from the American Academy of Periodontology Glossary of Periodontal Terms). The instrument used to measure the clinical attachment level is the periodontal probe. The periodontal is a calibrated probe used to measure the depth and determine the configuration of a periodontal pocket. (Definition from the American Academy of Periodontology Glossary of Periodontal Terms).

  baseline

• Bleeding on Probing (yes or no)

  Bleeding is observed or not observed around each of 6 surfaces for each individual tooth following the gentle probing into the gingiva to obtain the probing depth measurements (see definition of periodontal probing). Gingival bleeding indicates the presence of inflammation. Bleeding on probing is a standard of care observation/finding and clinical sign that indicates the presence of inflammation and the progression of periodontal disease.

  baseline

• Probing Depth (in millimeters)

  The distance from the soft tissue (gingiva or alveolar mucosa) margin to the tip of the periodontal probe during usual periodontal diagnostic probing. The health of the attachment apparatus can affect the measurement. (Definition from the American Academy of Periodontology Glossary of Periodontal Terms). The instrument used to measure the probing depth is the periodontal probe. The periodontal is a calibrated probe used to measure the depth and determine the configuration of a periodontal pocket. (Definition from the American Academy of Periodontology Glossary of Periodontal Terms).

  These will be collected at 3 months post-surgery.

• Clinical Attachment Level (in millimeters)

  The distance from the cemento-enamel junction to the tip of the periodontal probe during usual periodontal diagnostic probing. The health of the attachment apparatus can affect the measurement. (Definition from the American Academy of Periodontology Glossary of Periodontal Terms). The instrument used to measure the clinical attachment level is the periodontal probe. The periodontal is a calibrated probe used to measure the depth and determine the configuration of a periodontal pocket. (Definition from the American Academy of Periodontology Glossary of Periodontal Terms).

  These will be collected at 3 months post-surgery.

• Bleeding on Probing

  Bleeding is observed or not observed around each of 6 surfaces for each individual tooth following the gentle probing into the gingiva to obtain the probing depth measurements (see definition of periodontal probing). Gingival bleeding indicates the presence of inflammation. Bleeding on probing is a standard of care observation/finding and clinical sign that indicates the presence of inflammation and the progression of periodontal disease.

  These will be collected at 3 months post-surgery.

• Probing Depth (in millimeters)

  The distance from the soft tissue (gingiva or alveolar mucosa) margin to the tip of the periodontal probe during usual periodontal diagnostic probing. The health of the attachment apparatus can affect the measurement. (Definition from the American Academy of Periodontology Glossary of Periodontal Terms). The instrument used to measure the probing depth is the periodontal probe. The periodontal is a calibrated probe used to measure the depth and determine the configuration of a periodontal pocket. (Definition from the American Academy of Periodontology Glossary of Periodontal Terms).

  These will be collected at 6 months post-surgery.

• Clinical Attachment Level (in millimeters)

  The distance from the cemento-enamel junction to the tip of the periodontal probe during usual periodontal diagnostic probing. The health of the attachment apparatus can affect the measurement. (Definition from the American Academy of Periodontology Glossary of Periodontal Terms). The instrument used to measure the clinical attachment level is the periodontal probe. The periodontal is a calibrated probe used to measure the depth and determine the configuration of a periodontal pocket. (Definition from the American Academy of Periodontology Glossary of Periodontal Terms).

  These will be collected at 6 months post-surgery.

• Bleeding on Probing

  Bleeding is observed or not observed around each of 6 surfaces for each individual tooth following the gentle probing into the gingiva to obtain the probing depth measurements (see definition of periodontal probing). Gingival bleeding indicates the presence of inflammation. Bleeding on probing is a standard of care observation/finding and clinical sign that indicates the presence of inflammation and the progression of periodontal disease.

  These will be collected at 6 months post-surgery.

• Probing Depths (in millimeters)

  The distance from the soft tissue (gingiva or alveolar mucosa) margin to the tip of the periodontal probe during usual periodontal diagnostic probing. The health of the attachment apparatus can affect the measurement. (Definition from the American Academy of Periodontology Glossary of Periodontal Terms). The instrument used to measure the probing depth is the periodontal probe. The periodontal is a calibrated probe used to measure the depth and determine the configuration of a periodontal pocket. (Definition from the American Academy of Periodontology Glossary of Periodontal Terms).

  These will be collected at 1 year post-surgery.

• Clinical Attachment Level (in millimeters)

  The distance from the cemento-enamel junction to the tip of the periodontal probe during usual periodontal diagnostic probing. The health of the attachment apparatus can affect the measurement. (Definition from the American Academy of Periodontology Glossary of Periodontal Terms). The instrument used to measure the clinical attachment level is the periodontal probe. The periodontal is a calibrated probe used to measure the depth and determine the configuration of a periodontal pocket. (Definition from the American Academy of Periodontology Glossary of Periodontal Terms).

  These will be collected at 1 year post-surgery.

• Bleeding on Probing

  Bleeding is observed or not observed around each of 6 surfaces for each individual tooth following the gentle probing into the gingiva to obtain the probing depth measurements (see definition of periodontal probing). Gingival bleeding indicates the presence of inflammation. Bleeding on probing is a standard of care observation/finding and clinical sign that indicates the presence of inflammation and the progression of periodontal disease.

  These will be collected at 1 year post-surgery.

Secondary Outcomes (4)

• Bacterial Species Identification

  These will be collected at the initial visit

• Bacterial Species Identification

  These will be collected at 3 months post-surgery.

• Bacterial Species Identification

  These will be collected at 6 months post-surgery.

• Bacterial Species Identification

  These will be collected at 1 year post-surgery.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be identified at the Texas A\&M University dental school clinic.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University School of Dentistry

Dallas, Texas, 75246, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gingival crevicular fluid (collected through commercially available paper points) and saliva (collected through a tube) will be analyzed for detection of bacterial species. Analysis of saliva and gingival crevicular fluid is standard regimen and commercially available.

MeSH Terms

Conditions

Periodontal Diseases; Periodontal Pocket; Periodontitis; Periodontal Attachment Loss; Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Bone Resorption; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Carlos Parra Carrasquer, DDS

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: July 6, 2023
• Study Start: July 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)