Trial · NCT04954313
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Impact of Treatment on Change in Oral Health Measures | Comparing T1 (day 90) and T4 (day 360) | The impact of treatment on oral health measures, will be performed using generalized estimating equations (GEE) methods. Longitudinal outcomes in the Treated vs. Control groups will be compared and will include all subjects who were randomized and their data from visits T1 - T4 based on intent-to-treat (ITT) group assignment. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health. |
| Primary | Association Between Changes in Oral Health (Probing Depth) and Changes in Systemic Health (HbA1c) | Comparing T0 (day 0) and T4 (day 360) | The association between changes in oral health and changes in systemic health, will be evaluated using correlation analysis. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health. The correlation between % change in whole-mouth mean probing depth and % change in HbA1c will be determined in subjects with prediabetes or type 2 diabetes at screening. |
| Primary | Association Between Changes in Oral Health and Changes in Systemic Health (Flow-mediated Dilation) | Comparing T0 (day 0) and T4 (day 360) | The association between changes in oral health and changes in systemic health, will be evaluated using correlation analysis. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health. The correlation between % change in whole-mouth mean probing depth and change in flow-mediated dilation will be calculated. |
| Secondary | Change in Emotional Wellbeing | Comparing T0 (day 0) and T4 (day 360) | Emotional wellbeing will be evaluated through the use of PANAS (Positive Affect and Negative Affect Scales). PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure is change in the 10 item positive affect subscale. |
| Secondary | Change in Beliefs About Periodontal Disease | Comparing T0 (day 0) and T4 (day 360) | Beliefs about periodontal disease will be evaluated through the use of a Protective Motivation Theory (PMT) survey. PMT surveys assess an individual's motivation to adopt protective health behaviors by focusing on specific cognitive processes. This survey includes 7 statements related to opinions on periodontal disease and treatment (e.g., "Periodontal disease worries me," "Adhering to my periodontal treatment instructions over the next weeks will improve my oral health"). Each survey item is scored from 1 to 10 with 1 being "not at all" to 10 being "extremely so." Higher values indicate stronger agreement with the survey statements. Reported outcome measures represent total survey scores (range from 7 to 70). |
| Secondary | Change in Bleeding on Probing | Comparing T0 (day 0) and T4 (day 360) | Whole-mouth mean of tooth-specific dichotomic response (bleeding = 1, no bleeding = 0) after probing the gingival sulcus. |
| Secondary | Change in Gingival Index | Comparing T0 (day 0) and T4 (day 360) | The gingival index will be scored on three facial surfaces (distofacial, facial, mesiofacial) and three lingual surfaces (distolingual, lingual, mesiolingual). Areas are examined by placing the periodontal probe under the gingival margin at approximately 1mm deep and sweeping the probe from the distal surface to the mesial surface in quadrants I and IV and mesial to the distal surface in quadrants II and III. After each quadrant is swept, calls are made based on gingival inflammation and the presence or absence of bleeding according to criteria which range from 0 to 3. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation. For this Outcome Measure, less inflammation (lower number) correlates with better outcome. Reported outcome measure is whole-mouth mean value (six surfaces of each tooth), with a range of 0 to 3. |
| Secondary | Percent Change in Clinical Attachment Level (CAL) | Comparing T0 (day 0) and T4 (day 360) | Percent change of whole-mouth mean clinical attachment level (CAL, defined as measured pocket depth - gingival margin, for each site). Percent change calculated as (CAL@T4 - CAL@T0)/CAL@T0. |
| Secondary | Change in Dental Plaque Index | Comparing T0 (day 0) and T4 (day 360) | Change of digitally measured interdental plaque area. Full mouth plaque assessment shall be assessed using the UNC Modified Plaque Index (Greene and Vermillion). Plaque scores shall be visually assessed at 6 sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual surfaces) on a scale of 0-3. Scores are the following: 0 =No debris or stain present on the clinical crown; 1 =Soft debris covering not more than 1/3 of the clinical crown (cervical 3rd), or presence of extrinsic stains without other debris regardless of surface area covered; 2 =Soft debris covering more than 1/3, but not more than 2/3 (middle 3rd) of the clinical crown; 3 =Soft debris covering more than 2/3 of the clinical crown. Reported outcome measure is calculated as whole-mouth mean (mean of each site at each tooth) with a range of 0 to 3. |
| Secondary | Change in Flow-mediated Dilation | Comparing T0 (day 0) and T4 (day 360) | Change of flow mediated dilation. Ultrasound images of the right brachial artery and Doppler measures of arterial flow will be acquired before and after reactive hyperemia is induced by inflating a pneumatic occlusion cuff placed around the lower arm. FMD will be calculated as the percent change in arterial diameter from baseline. |
| Secondary | Percent Change in Glycated Hemoglobin (HbA1c) (Prediabetic and Type 2 Diabetic Cohorts) | Comparing T0 (day 0) and T4 (day 360) | Percent change of HbA1c (% glycated) from day 0 to day 360 \[(HbA1c@T4 - HbA1c@T0) / HbA1c@T0\] in the prediabetic and diabetic cohorts (HbA1c \>= 5.7 at screening) |
| Secondary | Percent Change in Carotid Intima Media Thickness (IMT) | Comparing T0 (day 0) and T4 (day 360) | Percent change of IMT. Longitudinal ultrasound images of the distal 1 cm segments of the right and left common carotid arteries, carotid bulbs, and internal carotid arteries will be acquired. IMT will be measured as the distance between luminal-intimal interface and medial-adventitial interface. Mean IMT will be calculated as the average of all measurements; mean maximum IMT will be calculated as the average of maximum wall thicknesses for each of the regions. Percent change of IMT (mm) from day 0 to day 360 is calculated as (IMT@T4 - IMT@T0) / IMT@T0\] |
| Secondary | Percent Change of High Sensitivity C-reactive Protein (Hs-CRP) | Comparing T0 (day 0) and T4 (day 360) | Percent change of hs-CRP (mg/dL) from day 0 to day 360 \[(CRP@T4 - CRP@T0) / CRP@T0\] |
| Secondary | Percent Change in Total Cholesterol | Comparing T0 (day 0) and T4 (day 360) | Percent change of total cholesterol (mg/dL) from day 0 to day 360 \[(tchol@T4 - tchol@T0) / tchol@T0\] |
| Secondary | Percent Change in Low Density Lipoprotein (LDL) Cholesterol | Comparing T0 (day 0) and T4 (day 360) | Percent change of low density lipoproteins (LDL) cholesterol (mg/dL) from day 0 to day 360 \[(LDL@T4 - LDL@T0) / LDL@T0\] |
| Secondary | Percent Change in Triglycerides | Comparing T0 (day 0) and T4 (day 360) | Percent change of triglycerides (mg/dL) from day 0 to day 360 \[(trig@T4 - trig@T0) / trig@T0\] |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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