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Clinical Trial Details

Trial ID: L5932
Source ID: NCT04954313
Associated Drug: Subgingival Chlorhexidine Irrigation
Title: Baseline Oral Health Study: UnCoVer the Connections to General Health
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Cardiovascular Diseases|Diabetes Type 2
Interventions: DRUG: Subgingival chlorhexidine irrigation|OTHER: Dental Supplies|OTHER: Periodonal Treatment
Outcome Measures: Primary: Impact of treatment on change in oral health measures, 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 used as a measure of oral health and measured per sextant., Comparing T1 (day 90) and T4 (day 360)|Association between changes in oral health and changes in systemic health (Glycated hemoglobin (HbA1c)), The association between changes in oral health and changes in systemic health, will be evaluated using correlation analysis. Periodontal probing depths will be used as a measure of oral health and measured per sextant. The strength of correlations between changes in oral health and change in HbA1c (in subjects with prediabetes or type 2 diabetes), Comparing baseline (day 0) and T4 (day 360)|Association between changes in oral health and changes in systemic health (Flow-mediated dilation), The association between changes in oral health and changes in systemic health, will be evaluated using correlation analysis. Periodontal probing depths will be used as a measure of oral health and measured per sextant. The strength of correlations between changes in oral health and change in flow-mediated dilation, Comparing baseline (day 0) and T4 (day 360) | Secondary: Impact of treatment on emotional wellbeing, 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., Comparing baseline (day 0) and T4 (day 360)|Impact of treatment on beliefs about periodontal disease, Emotional wellbeing will be evaluated through the use of PMT (Protective Motivation Theory questionnaire). The PMT is a total of 7 questions about opinions related to periodontal disease and treatment from 1 to 10 with 1 being not at all and 10 being extremely so., Comparing baseline (day 0) and T4 (day 360)|Impact of treatment on bleeding on probing, Dichotomic response after probing the gingival sulcus., Comparing baseline (day 0) and T4 (day 360)|Impact of treatment on gingival index, 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, Comparing baseline (day 0) and T4 (day 360)|Impact of treatment on clinical attachment level, Percent change of gingival margin position related to the crown margin, Comparing baseline (day 0) and T4 (day 360)|Impact of treatment on dental plaque index, Percent 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, Comparing baseline (day 0) and T4 (day 360)|Impact of treatment on flow-mediated dilation, Percent 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. Peak hyperemic flow will be expressed as the time-velocity integral of the Doppler velocity ., Comparing baseline (day 0) and T4 (day 360)|Impact of treatment on Glycated hemoglobin (HbA1c) (prediabetic and type 2 diabetic cohorts), Percent change of HbA1c, Comparing baseline (day 0) and T4 (day 360)|Impact of treatment on carotid intima media thickness (IMT), 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., Comparing baseline (day 0) and T4 (day 360)|Impact of treatment on high sensitivity C-reactive protein (hs-CRP), Percent change of hs-CRP, Comparing baseline (day 0) and T4 (day 360)|Impact of treatment on total cholesterol, Percent change of total cholesterol, Comparing baseline (day 0) and T4 (day 360)|Impact of treatment on low density lipoproteins (LDL) cholesterol, Percent change of LDL, Comparing baseline (day 0) and T4 (day 360)|Impact of treatment on triglycerides, Percent change of triglycerides, Comparing baseline (day 0) and T4 (day 360)
Sponsor/Collaborators: Sponsor: University of North Carolina, Chapel Hill | Collaborators: Colgate Palmolive
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 200
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2021-09-28
Completion Date: 2025-02
Results First Posted:
Last Update Posted: 2024-06-07
Locations: University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States|UNC Nutrition Research Institute, Kannapolis, North Carolina, 28081, United States
URL: https://clinicaltrials.gov/show/NCT04954313