Cardiovascular DiseasesPhase 4NCT04954313
Baseline Oral Health Study: UnCoVer the Connections to General Health
A Phase 4 study testing Subgingival chlorhexidine irrigation, Dental Supplies and Periodonal Treatment in people with Cardiovascular Diseases and Diabetes Type 2, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
Purpose: The Baseline Oral Health Health Study is a randomized controlled trial to evaluate the impact of regular, professional non-surgical Intensive Periodontal Therapy (scaling and root planing and optimal oral hygiene with associated professional oral health behavior advice ), on oral health as well as whether… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Diabetes Type 2
- What is being tested?
- Subgingival chlorhexidine irrigation, Dental Supplies and Periodonal Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 786 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Sep 2021to 1 Feb 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least eighteen (18) years of age but not older than seventy (70) years of age at the time of screening
- Able to speak and read English
- Has at least 16 teeth present.
- Able to consent, follow an outpatient protocol, and is available by telephone
- Has either moderate (stage II) or severe (stage III) periodontitis:
- Stage II - Interdental clinical attachment level (CAL) at the site of greatest loss = 3 to 4mm with maximum probing depth ≤ 5mm
Show all 13Show fewer
- Stage III - Interdental CAL at the site of greatest loss ≥ 5mm, probing depth (PD)≥ 6mm, and radiographic bone loss (vertical bone loss ≥ 3mm)
- Has at least one of the following indicators of cardiometabolic disease in the following range:
- Type 2 diabetes: 9% ≥ HbA1c ≥ 6.5% OR Prediabetes: 6.4%≥ HbA1c ≥ 5.7% OR
- Cardiovascular Disease (CVD):
- Medical history of Myocardial Infarction, Coronary Artery Disease or stroke
- Access to Apple (iOS) devices or Android devices with appropriate versions to be compatible with the applications to complete study procedures.
- Females of childbearing capacity must be willing to have pregnancy test
Who cannot join
- Individuals who exhibit gross oral pathology
- Presenting oral manifestations of systemic diseases (e.g. pemphigus, pemphigoid, lupus)
- Presence of any acute or chronic systemic infection as determined by the clinician
- Periodontal treatment performed within 6 months prior to study start
- Refusal to extract hopeless teeth identified as determined by the clinician at the screening visit.
- Participating in any other interventional cardiometabolic or Oral Health study
- Individuals currently undergoing any type of orthodontic treatment (e.g. aligners)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
UNC Nutrition Research Institute
Kannapolis, North Carolina, 28081
About this study
Purpose: The Baseline Oral Health Health Study is a randomized controlled trial to evaluate the impact of regular, professional non-surgical Intensive Periodontal Therapy (scaling and root planing and optimal oral hygiene with associated professional oral health behavior advice ), on oral health as well as whether such effects are associated with corresponding changes to biomarkers characterizing systemic health.
Participants: The Baseline Oral Health Study will enroll approximately 200 participants in the study with approximately 100 participants each within the Control Group and the Treatment Group. The study population will be recruited from the Project Baseline Health Study participants in the North Carolina region and may be expanded to include subjects recruited from University of North Carolina (UNC) if the initial screening from Project Baseline Health Study pool of participants in the North Carolina region does not fulfill study enrollment powering.
Procedures (methods): The study population will be recruited from Project Baseline Health Study participants. The Project Baseline Health Study is a longitudinal cohort study which characterizes participants across clinical, molecular, imaging, sensor, self-reported, behavioral, psychological, environmental, or other health-related measurements from onsite and/or remote visits, continuous monitoring through sensor technology, and regular engagement via an online portal, and mobile app. The study population will be recruited from Project Baseline Health Study participants diagnosed with cardiovascular disease and/or type 2 diabetes mellitus (including prediabetes) and eligible for periodontal intervention. The study will use dental centers and an experienced dental team to manage the oral care provided in this study.
Read the detailed description
The Baseline Oral Health Health Study is a randomized controlled trial to evaluate the impact of regular, professional non-surgical Intensive Periodontal Therapy (scaling and root planing and optimal oral hygiene with associated professional oral health behavior advice ), on oral health as well as whether such effects are associated with corresponding changes to biomarkers characterizing systemic health. The study will be conducted in partnership with Verily and the Project Baseline Team, Colgate, and the University of North Carolina. The study population will be recruited from Project Baseline Health Study participants. The Project Baseline Health Study is a longitudinal cohort study which characterizes participants across clinical, molecular, imaging, sensor, self-reported, behavioral, psychological, environmental, or other health-related measurements from onsite and/or remote visits, continuous monitoring through sensor technology, and regular engagement via an online portal, and mobile app.
The study population will be recruited from Project Baseline Health Study participants diagnosed with cardiovascular disease and/or type 2 diabetes mellitus (including prediabetes) and eligible for periodontal intervention. The study will use dental centers and an experienced dental team to manage the oral care provided in this study.
- Conditions
- Cardiovascular Diseases, Diabetes Type 2
- Being tested
- Subgingival chlorhexidine irrigation, Dental Supplies, Periodonal Treatment
- Keywords
- Oral health
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subgingival chlorhexidine irrigationDrug
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).
Dental SuppliesOther
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.
Periodonal TreatmentOther
Initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planing (SRP).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 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. Receives: Drug: Subgingival chlorhexidine irrigation; Other: Dental Supplies; Other: Periodonal Treatment |
| Control Group | Active comparator | 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. Receives: Other: Periodonal Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Comparing T1 (day 90) and T4 (day 360)
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.
Measured: Comparing T0 (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 (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.
Measured: Comparing T0 (day 0) and T4 (day 360)
Secondary outcomes (13)
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.
Measured: Comparing T0 (day 0) and T4 (day 360)
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).
Measured: Comparing T0 (day 0) and T4 (day 360)
Change in Bleeding on Probing
Whole-mouth mean of tooth-specific dichotomic response (bleeding = 1, no bleeding = 0) after probing the gingival sulcus.
Measured: Comparing T0 (day 0) and T4 (day 360)
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.
Measured: Comparing T0 (day 0) and T4 (day 360)
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.
Measured: Comparing T0 (day 0) and T4 (day 360)
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.
Measured: Comparing T0 (day 0) and T4 (day 360)
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.
Measured: Comparing T0 (day 0) and T4 (day 360)
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)
Measured: Comparing T0 (day 0) and T4 (day 360)
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]
Measured: Comparing T0 (day 0) and T4 (day 360)
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]
Measured: Comparing T0 (day 0) and T4 (day 360)
Percent Change in Total Cholesterol
Percent change of total cholesterol (mg/dL) from day 0 to day 360 [(tchol@T4 - tchol@T0) / tchol@T0]
Measured: Comparing T0 (day 0) and T4 (day 360)
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]
Measured: Comparing T0 (day 0) and T4 (day 360)
Percent Change in Triglycerides
Percent change of triglycerides (mg/dL) from day 0 to day 360 [(trig@T4 - trig@T0) / trig@T0]
Measured: Comparing T0 (day 0) and T4 (day 360)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start28 Sep 2021
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 786 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Colgate Palmolive
- Responsible party
- Sponsor
- Investigators
- Saroja Voruganti, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954313
- Sponsor's protocol ID
- 21-1453
- Other IDs
- CRO-2020-03-VERILY-LK
- Status last verified
- May 2025
- First submitted
- 22 Jun 2021
- Last updated
- 12 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Oral Health Study: UnCoVer the Connections to General Health
- ClinicalTrials.gov ID
- NCT04954313
- Acronym / sponsor ID
- 21-1453
- Conditions
- Cardiovascular Diseases, Diabetes Type 2
- Keywords
- Oral health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 786 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Colgate Palmolive
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Posted 12 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: The Baseline Oral Health Health Study is a randomized controlled trial to evaluate the impact of regular, professional non-surgical Intensive Periodontal Therapy (scaling and root planing and optimal oral hygiene with associated professional oral health behavior advice ), on oral health as well as whether such effects are associated with corresponding changes to biomarkers characterizing systemic health.
Participants: The Baseline Oral Health Study will enroll approximately 200 participants in the study with approximately 100 participants each within the Control Group and the Treatment Group. The study population will be recruited from the Project Baseline Health Study participants in the North Carolina region and may be expanded to include subjects recruited from University of North Carolina (UNC) if the initial screening from Project Baseline Health Study pool of participants in the North Carolina region does not fulfill study enrollment powering.
Procedures (methods): The study population will be recruited from Project Baseline Health Study participants. The Project Baseline Health Study is a longitudinal cohort study which characterizes participants across clinical, molecular, imaging, sensor, self-reported, behavioral, psychological, environmental, or other health-related measurements from onsite and/or remote visits, continuous monitoring through sensor technology, and regular engagement via an online portal, and mobile app. The study population will be recruited from Project Baseline Health Study participants diagnosed with cardiovascular disease and/or type 2 diabetes mellitus (including prediabetes) and eligible for periodontal intervention. The study will use dental centers and an experienced dental team to manage the oral care provided in this study.
Detailed description
The Baseline Oral Health Health Study is a randomized controlled trial to evaluate the impact of regular, professional non-surgical Intensive Periodontal Therapy (scaling and root planing and optimal oral hygiene with associated professional oral health behavior advice ), on oral health as well as whether such effects are associated with corresponding changes to biomarkers characterizing systemic health. The study will be conducted in partnership with Verily and the Project Baseline Team, Colgate, and the University of North Carolina. The study population will be recruited from Project Baseline Health Study participants. The Project Baseline Health Study is a longitudinal cohort study which characterizes participants across clinical, molecular, imaging, sensor, self-reported, behavioral, psychological, environmental, or other health-related measurements from onsite and/or remote visits, continuous monitoring through sensor technology, and regular engagement via an online portal, and mobile app.
The study population will be recruited from Project Baseline Health Study participants diagnosed with cardiovascular disease and/or type 2 diabetes mellitus (including prediabetes) and eligible for periodontal intervention. The study will use dental centers and an experienced dental team to manage the oral care provided in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Subgingival chlorhexidine irrigation, Other: Dental Supplies, Other: Periodonal TreatmentThe 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. |
| Control Group | Active comparator | Other: Periodonal TreatmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- At least eighteen (18) years of age but not older than seventy (70) years of age at the time of screening
- Able to speak and read English
- Has at least 16 teeth present.
- Able to consent, follow an outpatient protocol, and is available by telephone
- Has either moderate (stage II) or severe (stage III) periodontitis:
Key exclusion criteria (7 listed)
- Individuals who exhibit gross oral pathology
- Presenting oral manifestations of systemic diseases (e.g. pemphigus, pemphigoid, lupus)
- Presence of any acute or chronic systemic infection as determined by the clinician
- Periodontal treatment performed within 6 months prior to study start
- Refusal to extract hopeless teeth identified as determined by the clinician at the screening visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subgingival chlorhexidine irrigationThe 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). | Drug | Treatment Group |
| Dental SuppliesSubjects 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. | Other | Treatment Group |
| Periodonal TreatmentInitial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planing (SRP). | Other | Control Group, Treatment Group |
Primary outcome
Impact of Treatment on Change in Oral Health Measures
Time frame: 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.
Association Between Changes in Oral Health (Probing Depth) and Changes in Systemic Health (HbA1c)
Time frame: 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.
Association Between Changes in Oral Health and Changes in Systemic Health (Flow-mediated Dilation)
Time frame: 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.
13 secondary outcomes
Change in Emotional Wellbeing
Time frame: Comparing T0 (day 0) and T4 (day 360)
Change in Beliefs About Periodontal Disease
Time frame: Comparing T0 (day 0) and T4 (day 360)
Change in Bleeding on Probing
Time frame: Comparing T0 (day 0) and T4 (day 360)
Change in Gingival Index
Time frame: Comparing T0 (day 0) and T4 (day 360)
Percent Change in Clinical Attachment Level (CAL)
Time frame: Comparing T0 (day 0) and T4 (day 360)
Change in Dental Plaque Index
Time frame: Comparing T0 (day 0) and T4 (day 360)
Change in Flow-mediated Dilation
Time frame: Comparing T0 (day 0) and T4 (day 360)
Percent Change in Glycated Hemoglobin (HbA1c) (Prediabetic and Type 2 Diabetic Cohorts)
Time frame: Comparing T0 (day 0) and T4 (day 360)
Percent Change in Carotid Intima Media Thickness (IMT)
Time frame: Comparing T0 (day 0) and T4 (day 360)
Percent Change of High Sensitivity C-reactive Protein (Hs-CRP)
Time frame: Comparing T0 (day 0) and T4 (day 360)
Percent Change in Total Cholesterol
Time frame: Comparing T0 (day 0) and T4 (day 360)
Percent Change in Low Density Lipoprotein (LDL) Cholesterol
Time frame: Comparing T0 (day 0) and T4 (day 360)
Percent Change in Triglycerides
Time frame: Comparing T0 (day 0) and T4 (day 360)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saroja Voruganti, PhD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Subgingival chlorhexidine irrigation, Dental Supplies and Periodonal Treatment in people with Cardiovascular Diseases and Diabetes Type 2, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Treatment on Change in Oral Health Measures (time frame: Comparing T1 (day 90) and T4 (day 360)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.