Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT05932017

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Periodontal Diseases Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Attachment Loss Periodontal Bone Loss Periodontal Inflammation Periodontal Pocket Periodontitis Stomatognathic Diseases Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas A&M University School of Dentistry

Dallas, Texas, 75246, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Probing Depth (in millimeters)

    Time frame: baseline

    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).

  2. Clinical Attachment Level (in millimeters)

    Time frame: baseline

    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).

  3. Bleeding on Probing (yes or no)

    Time frame: baseline

    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.

  4. Probing Depth (in millimeters)

    Time frame: These will be collected at 3 months post-surgery.

    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).

  5. Clinical Attachment Level (in millimeters)

    Time frame: These will be collected at 3 months post-surgery.

    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).

  6. Bleeding on Probing

    Time frame: These will be collected at 3 months post-surgery.

    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.

  7. Probing Depth (in millimeters)

    Time frame: These will be collected at 6 months post-surgery.

    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).

  8. Clinical Attachment Level (in millimeters)

    Time frame: These will be collected at 6 months post-surgery.

    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).

  9. Bleeding on Probing

    Time frame: These will be collected at 6 months post-surgery.

    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.

  10. Probing Depths (in millimeters)

    Time frame: These will be collected at 1 year post-surgery.

    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).

  11. Clinical Attachment Level (in millimeters)

    Time frame: These will be collected at 1 year post-surgery.

    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).

  12. Bleeding on Probing

    Time frame: These will be collected at 1 year post-surgery.

    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.

Secondary outcomes

  1. Bacterial Species Identification

    Time frame: These will be collected at the initial visit

    Fluid from just underneath the subject's gums will be collected using a using a commercially available test (paper strip). The strip will be analyzed for bacteria. Minimal discomfort is associated with this procedure. The bacterial sampling is not routinely done in our clinic and considered to be a research only procedure. The test samples will be analyzed by OralDNA® Labs.

  2. Bacterial Species Identification

    Time frame: These will be collected at 3 months post-surgery.

    Fluid from just underneath the subject's gums will be collected using a using a commercially available test (paper strip). The strip will be analyzed for bacteria. Minimal discomfort is associated with this procedure. The bacterial sampling is not routinely done in our clinic and considered to be a research only procedure. The test samples will be analyzed by OralDNA® Labs.

  3. Bacterial Species Identification

    Time frame: These will be collected at 6 months post-surgery.

    Fluid from just underneath the subject's gums will be collected using a using a commercially available test (paper strip). The strip will be analyzed for bacteria. Minimal discomfort is associated with this procedure. The bacterial sampling is not routinely done in our clinic and considered to be a research only procedure. The test samples will be analyzed by OralDNA® Labs.

  4. Bacterial Species Identification

    Time frame: These will be collected at 1 year post-surgery.

    Fluid from just underneath the subject's gums will be collected using a using a commercially available test (paper strip). The strip will be analyzed for bacteria. Minimal discomfort is associated with this procedure. The bacterial sampling is not routinely done in our clinic and considered to be a research only procedure. The test samples will be analyzed by OralDNA® Labs.

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 6, 2023
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.