NCT04954313CompletedPhase 4
Baseline Oral Health Study: UnCoVer the Connections to General Health
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 786 (actual)
- First submitted
- 22 Jun 2021
- Start date
- 28 Sept 2021
- Primary completion date
- 1 Feb 2025
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Type 2 diabetes
- NCT number
- NCT04954313
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 786
- From 28 Sept 2021 to the primary completion date, 1 Feb 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Periodontal treatment performed within 6 months prior to study start
Other illness
- Presenting oral manifestations of systemic diseases (e.g. pemphigus, pemphigoid, lupus)
- Presence of any acute or chronic systemic infection as determined by the clinician
Other
- Individuals who exhibit gross oral pathology
- 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)
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| UNC Nutrition Research Institute Coordinator of this site? Confirm its status | Kannapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.