Surgery Clinical Trial
Official title:
Comparison of Gingival Flap Procedure Using Conventional Surgical Loupes vs. Videoscope for Visualization. A Pilot Study
Verified date | March 2023 |
Source | Texas A&M University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 20 |
Est. completion date | March 2025 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Texas A&M University School of Dentistry | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas A&M University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | Bacterial Species Identification | 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. | These will be collected at the initial visit | |
Secondary | Bacterial Species Identification | 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. | These will be collected at 3 months post-surgery. | |
Secondary | Bacterial Species Identification | 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. | These will be collected at 6 months post-surgery. | |
Secondary | Bacterial Species Identification | 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. | These will be collected at 1 year post-surgery. |
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