Baseline Oral Health Study: UnCoVer the Connections to General Health

Browse trials for

• Cardiovascular Diseases 4,902
• Diabetes Mellitus, Type 2 9,357

Keywords

• Oral health

Cardiovascular Diseases

4,902 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.

This study's enrollment of 786 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Study arms

• Experimental
  Treatment Group

  The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.

  Drug: Subgingival chlorhexidine irrigation · Other: Dental Supplies · Other: Periodonal Treatment

• Active comparator
  Control Group

  The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP). Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.

  Other: Periodonal Treatment

Interventions

• DrugSubgingival chlorhexidine irrigation

  The dose information for the Chlorhexidine gluconate will be 0.12% with 1 mL in each dental pocket at a frequency of every 3 months for the duration of the study (18 months).

• OtherDental Supplies

  Subjects in the Treatment Group will receive a commercial electric toothbrush (Colgate hum), toothpaste (Colgate Renewal), mouthwash (Colgate Zero), proxabrush (Colgate), and floss (Colgate Palmolive brand) to be used at home along with instructions on their use. Brush heads for the electric toothbrush will be replaced every 3 months and products (toothpaste, mouthwash, proxabrush, and floss) will be replenished at every site visit.

• OtherPeriodonal Treatment

  Initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planing (SRP).

Primary outcomes

1. 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 measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health.

   Time frame: Comparing T1 (day 90) and T4 (day 360)

2. Association Between Changes in Oral Health (Probing Depth) and Changes in Systemic Health (HbA1c)

   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.

   Time frame: Comparing T0 (day 0) and T4 (day 360)

3. 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 (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.

   Time frame: Comparing T0 (day 0) and T4 (day 360)

Secondary outcomes

1. Change in 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.

   Time frame: Comparing T0 (day 0) and T4 (day 360)

2. Change in Beliefs About Periodontal Disease

   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).

   Time frame: Comparing T0 (day 0) and T4 (day 360)

3. Change in Bleeding on Probing

   Whole-mouth mean of tooth-specific dichotomic response (bleeding = 1, no bleeding = 0) after probing the gingival sulcus.

   Time frame: Comparing T0 (day 0) and T4 (day 360)

4. Change in 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. 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.

   Time frame: Comparing T0 (day 0) and T4 (day 360)

5. Percent Change in Clinical Attachment Level (CAL)

   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.

   Time frame: Comparing T0 (day 0) and T4 (day 360)

6. Change in Dental Plaque Index

   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.

   Time frame: Comparing T0 (day 0) and T4 (day 360)

7. Change in Flow-mediated Dilation

   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.

   Time frame: Comparing T0 (day 0) and T4 (day 360)

8. Percent Change in Glycated Hemoglobin (HbA1c) (Prediabetic and Type 2 Diabetic Cohorts)

   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)

   Time frame: Comparing T0 (day 0) and T4 (day 360)

9. Percent Change in 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. Percent change of IMT (mm) from day 0 to day 360 is calculated as (IMT@T4 - IMT@T0) / IMT@T0\]

   Time frame: Comparing T0 (day 0) and T4 (day 360)

10. Percent Change of High Sensitivity C-reactive Protein (Hs-CRP)

    Percent change of hs-CRP (mg/dL) from day 0 to day 360 \[(CRP@T4 - CRP@T0) / CRP@T0\]

    Time frame: Comparing T0 (day 0) and T4 (day 360)

11. Percent Change in Total Cholesterol

    Percent change of total cholesterol (mg/dL) from day 0 to day 360 \[(tchol@T4 - tchol@T0) / tchol@T0\]

    Time frame: Comparing T0 (day 0) and T4 (day 360)

12. Percent Change in Low Density Lipoprotein (LDL) Cholesterol

    Percent change of low density lipoproteins (LDL) cholesterol (mg/dL) from day 0 to day 360 \[(LDL@T4 - LDL@T0) / LDL@T0\]

    Time frame: Comparing T0 (day 0) and T4 (day 360)

13. Percent Change in Triglycerides

    Percent change of triglycerides (mg/dL) from day 0 to day 360 \[(trig@T4 - trig@T0) / trig@T0\]

    Time frame: Comparing T0 (day 0) and T4 (day 360)

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · May 2, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Supporting information: Study protocol