Trial · NCT04954313
Baseline Oral Health Study: UnCoVer the Connections to General Health
NCT04954313, Phase 4, Completed, University of North Carolina, Chapel Hill; results first posted 2026-02-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Baseline Oral Health Study: UnCoVer the Connections to General Health. Trials, record NCT04954313. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04954313
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Baseline Oral Health Study: UnCoVer the Connections to General Health
- NCT number
- NCT04954313
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 786 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Cardiovascular Diseases, Diabetes Type 2
- Interventions
- Subgingival chlorhexidine irrigation, Dental Supplies, Periodonal Treatment
- First posted
- 2021-07-08
- Last updated
- 2026-02-12
- Results first posted
- 2026-02-12
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Impact of Treatment on Change in Oral Health Measures | Comparing T1 (day 90) and T4 (day 360) | Data include imputation. Predictions based on linear mixed models were used for imputation. | millimeters (probing depth difference) | LEAST_SQUARES_MEAN |
| PRIMARY | Association Between Changes in Oral Health (Probing Depth) and Changes in Systemic Health (HbA1c) | Comparing T0 (day 0) and T4 (day 360) | Analysis population includes only participants meeting the following criteria: (1) HbA1c data was available at T0 and T4 time points, (2) probing depth data was available at T0 and T4 time points, and (3) screening HbA1c \>= 5.7 (if screening value was not available, T0 value of HbA1c \>= 5.7 was used as proxy). | Pearson correlation coefficient | NUMBER |
| PRIMARY | Association Between Changes in Oral Health and Changes in Systemic Health (Flow-mediated Dilation) | Comparing T0 (day 0) and T4 (day 360) | Analysis population includes only participants meeting the following criteria: (1) flow mediated dilation data was available at T0 and T4 time points, (2) probing depth data was available at T0 and T4 time points. | Pearson correlation coefficient | NUMBER |
| SECONDARY | Change in Emotional Wellbeing | Comparing T0 (day 0) and T4 (day 360) | Analysis population includes only participants who completed the survey at T0 and T4 time points. | scores on a scale | MEAN |
| SECONDARY | Change in Beliefs About Periodontal Disease | Comparing T0 (day 0) and T4 (day 360) | Analysis population includes only participants who completed the survey at T0 and T4 time points. | scores on a scale | MEAN |
| SECONDARY | Change in Bleeding on Probing | Comparing T0 (day 0) and T4 (day 360) | Analysis population includes only participants who received dental assessment at T0 and T4 time points. | scores on a scale | MEAN |
| SECONDARY | Change in Gingival Index | Comparing T0 (day 0) and T4 (day 360) | Analysis population includes only participants who received dental assessment at T0 and T4 time points. | scores on a scale | MEAN |
| SECONDARY | Percent Change in Clinical Attachment Level (CAL) | Comparing T0 (day 0) and T4 (day 360) | Analysis population includes only participants who received dental assessment at T0 and T4 time points. | % change | MEAN |
| SECONDARY | Change in Dental Plaque Index | Comparing T0 (day 0) and T4 (day 360) | Analysis population includes only participants who received dental assessment at T0 and T4 time points. | scores on a scale | MEAN |
| SECONDARY | Change in Flow-mediated Dilation | Comparing T0 (day 0) and T4 (day 360) | Some participants did not have FMD measured at T0 and/or T4 and are not included in the T4-T0 comparison. Missing data arises from a combination of participant withdrawal/loss to followup and poor ultrasound data quality. | % change | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Impact of Treatment on Change in Oral Health Measures | Control Group | 0.186 | 95% Confidence Interval 0.0863 to 0.285 | millimeters (probing depth difference) | |
| Impact of Treatment on Change in Oral Health Measures | Treatment Group | 0.190 | 95% Confidence Interval 0.0737 to 0.306 | millimeters (probing depth difference) | |
| Association Between Changes in Oral Health (Probing Depth) and Changes in Systemic Health (HbA1c) | Control Group | -0.093 | 0.379 | Pearson correlation coefficient | |
| Association Between Changes in Oral Health (Probing Depth) and Changes in Systemic Health (HbA1c) | Treatment Group | -0.282 | 0.5123 | Pearson correlation coefficient | |
| Association Between Changes in Oral Health and Changes in Systemic Health (Flow-mediated Dilation) | Control Group | -0.0528 | 0.3635 | Pearson correlation coefficient | |
| Association Between Changes in Oral Health and Changes in Systemic Health (Flow-mediated Dilation) | Treatment Group | 0.006 | 0.5227 | Pearson correlation coefficient | |
| Change in Emotional Wellbeing | Control Group | 1.25 | Standard Deviation 6.93 | scores on a scale | |
| Change in Emotional Wellbeing | Treatment Group | -0.6 | Standard Deviation 7.09 | scores on a scale | |
| Change in Beliefs About Periodontal Disease | Control Group | 2.56 | Standard Deviation 8.75 | scores on a scale | |
| Change in Beliefs About Periodontal Disease | Treatment Group | -0.60 | Standard Deviation 4.47 | scores on a scale |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control Group | 73 | |
| Overall Study | STARTED | Treatment Group | 82 | |
| Overall Study | Completed T0 (Day 0) | Control Group | 73 | |
| Overall Study | Completed T0 (Day 0) | Treatment Group | 80 | |
| Overall Study | Completed T1 (Day 90) | Control Group | 65 | |
| Overall Study | Completed T1 (Day 90) | Treatment Group | 70 | |
| Overall Study | Completed T2 (Day 180) | Control Group | 61 | |
| Overall Study | Completed T2 (Day 180) | Treatment Group | 65 | |
| Overall Study | Completed T3 (Day 270) | Control Group | 56 | |
| Overall Study | Completed T3 (Day 270) | Treatment Group | 57 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Pancreatitis | Gastrointestinal disorders | Control Group | 1 | 73 | |
| serious | Pancreatitis | Gastrointestinal disorders | Treatment Group | 0 | 80 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control Group | 1 | 73 |
| Total, all-cause mortality | Treatment Group | 0 | 80 |
| Total, other adverse events | Control Group | 0 | 73 |
| Total, other adverse events | Treatment Group | 0 | 80 |
| Total, serious adverse events | Control Group | 1 | 73 |
| Total, serious adverse events | Treatment Group | 0 | 80 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment Group vs Control Group: deaths from any cause | Trial comparisons |
| Treatment Group vs Control Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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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