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Clinical Trial Details

Trial ID: L3666
Source ID: NCT04830969
Associated Drug: Chlorhexidine Gluconate Oral Rinse
Title: Impact of Periodontal Therapy on Patients With Diabetes
Acronym: DMRCT
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04830969/results
Conditions: Diabetes Mellitus, Type II|Periodontitis
Interventions: DRUG: Chlorhexidine gluconate oral rinse|PROCEDURE: Scaling & Root Planing|DEVICE: Soft Picks
Outcome Measures: Primary: Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline, Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured, Baseline to 6 months | Secondary: Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline, Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured, Baseline to 3 months|Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline, The distance from the Cemento-enamel Junction (CEJ) to the free gingival margin is measured with a periodontal probe. Millimeters of recession (loss of attachment) is recorded as a negative number; when the gingival margin is above the CEJ, the measurement (in millimeters) is recorded as positive., Baseline to 3 months;Baseline to 6 months|Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline, The analysis is based on the measures of each participant. Participant instead of site is used as unite for arm/group. The measure, % sites with probing pocket depth \>= 4 mm within each participant, indicates the portion of deep pocket in a participant. Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; The percentage of sites with Periodontal PD \>= 4 mm within each participant was compared between measured time points., Baseline to 3 months; Baseline to 6 months|Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline, The analysis is based on the measures of each participant. 0 is the absence of gingival bleeding and 1 is the presence of gingival bleeding after probing and measuring for pocket depth. Bleeding on probing index is defined as the percentage of sites with presence of gingival bleeding after probing per participant. The value of bleeding on probing index ranges from 0 to 100 for each participant. The bleeding on probing index per participant is compared between time points measured., Baseline to 3 months; Baseline to 6 months|Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline, The analysis is based on the measures of each participant. Plaque is visually measured on 6 sites per tooth; 0 is the absence of any plaque. 1 is the presence of plaque. For each participant, 6 sites per tooth are evaluated. The Plaque Index (PI) of each participant is defined as the percentage of sites with plaque. The value of PI ranges from 0 to 100 for each participant. The PI of each participant is assessed and compared between measured time points., Baseline to 3 months; Baseline to 6 months|Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics, Probing depth (PD) or probing pocket depth (PPD), measured on six surfaces/tooth, is the distance in millimeters (mm) from the gingival margin to the base of the gingival pocket, Baseline to 3 months; Baseline to 6 months|Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics, The distance from the Cemento-enamel Junction (CEJ) to the free gingival margin is measured with a periodontal probe. Millimeters of recession (loss of attachment) is recorded as a negative number; when the gingival margin is above the CEJ, the measurement (in millimeters) is recorded as positive., Baseline to 3 months; Baseline to 6 months|Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline in Diabetics and Non-diabetics, The analysis is based on the measure of each participant. Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; The percentage of sites with Periodontal PD \>= 4 mm per participant is compared between measured time points., Baseline to 3 months; Baseline to 6 months|Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics, The analysis is based on the measures of each participant. 0 is the absence of gingival bleeding and 1 is the presence of gingival bleeding after probing and measuring for pocket depth. Bleeding on probing index is defined as the percentage of sites with presence of gingival bleeding after probing per participant. The value of bleeding on probing index ranges from 0 to 100 for each participant. The bleeding on probing index per participant is compared between time points measured., Baseline to 3 months; Baseline to 6 months|Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics, The analysis is based on the measures of each participant. Plaque is visually measured on 6 sites per tooth; 0 is the absence of any plaque. 1 is the presence of plaque. For each participant, 6 sites per tooth are evaluated. The Plaque Index (PI) of each participant is defined as the percentage of sites with plaque. The value of PI ranges from 0 to 100 for each participant. The PI of each participant is assessed and compared between measured time points., Baseline to 3 months; Baseline to 6 months|Changes in Hemoglobin A1c at 6 Months After Treatment, Hemoglobin in A1c (HbA1c) tells the average level of blood sugar over the prior 2 to 3 months. Normal level is below 5.7%; 5.7%-6.4% indicates prediabetes; greater than 6.5% is indicative of diabetes., Baseline to 6 months|Changes in Fasting Blood Glucose at 6 Months After Treatment, Fasting blood sugar/glucose (FBS/FBG) is tested with a blood sample taken after an overnight fast. A fasting blood sugar level less than 100 mg/dL is normal; a fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes; a level 126 mg/dL (7 mmol/L) or higher on two separate tests, indicates diabetes., Baseline to 6 months|Change in High Sensitivity C-reactive Protein at 6 Months After Treatment, The high-sensitivity C-reactive protein (hs-CRP) blood test measures body inflammation indicating infection or a chronic inflammatory disease such as periodontitis or diabetes. It also can be used to evaluate risk of developing coronary artery disease. A normal reading is less than 10 milligram per liter (mg/L); a level greater than 10 mg/L is a sign of serious infection, trauma or chronic disease likely requiring further testing to determine cause, Baseline to 6 months|Changes in Hemoglobin A1c at 6 Months After Treatment in Diabetics and Non-diabetics, Hemoglobin in A1c (HbA1c) tells the average level of blood sugar over the prior 2 to 3 months. Normal level is below 5.7%; 5.7%-6.4% indicates prediabetes; greater than 6.5% is indicative of diabetes., Baseline to 6 months|Changes in Fasting Blood Glucose at 6 Months After Treatment in Diabetics and Non-diabetics, Fasting blood sugar/glucose (FBS/FBG) is tested with a blood sample taken after an overnight fast. A fasting blood sugar level less than 100 mg/dL is normal; a fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes; a level 126 mg/dL (7 mmol/L) or higher on two separate tests, indicates diabetes., Baseline to 6 months|Change in High Sensitivity C-reactive Protein at 6 Months After Treatment in Diabetics and Non-diabetics, The high-sensitivity C-reactive protein (hs-CRP) blood test measures body inflammation indicating infection or a chronic inflammatory disease such as periodontitis or diabetes. It also can be used to evaluate risk of developing coronary artery disease. A normal reading is less than 10 milligram per liter (mg/L); a level greater than 10 mg/L is a sign of serious infection, trauma or chronic disease likely requiring further testing to determine cause, Baseline to 6 months|Shannon Index of the Subgingival Plaque Microbiome at Baseline and 6 Months, Shannon index represents mean species diversity in a site at a local scale. Shannon index quantifies the uncertainty in predicting the species identity of an individual that is taken at random from the dataset. The minimum value is 0 and there is no maximum value. High values mean high species diversities., Baseline; 6 Months|Change in Distance to the Healthy Plane Based on the Subgingival Plaque Microbiome at 6 Months, Analysis of microbiome community changes using the healthy plane (HP) as a reference. A healthy plane was calculated by fitting a plane that minimizes the sum of squares of distances from HC samples to the nearest point on the plane. The distance of each sample to the HP was then calculated. Higher values of distance to HP mean microbiome community changes towards disease status, Baseline to 6 Months
Sponsor/Collaborators: Sponsor: State University of New York at Buffalo | Collaborators: Sunstar, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 116
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2016-11-08
Completion Date: 2021-01-28
Results First Posted: 2023-03-01
Last Update Posted: 2023-03-01
Locations: University at Buffalo, Buffalo, New York, 14214, United States
URL: https://clinicaltrials.gov/show/NCT04830969