Baseline Oral Health Study: UnCoVer the Connections to General Health

21-1453

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.

2021-09-28

2025-02-01

2025-02-01

Active (not recruiting)

Early phase I

200

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The investigator and all sub-investigators will make every effort to remain blinded as to the subject regimen. Periodontal treatment throughout the Study will be provided only by experienced general dentists, periodontists or dental hygienists who are licensed, trained and calibrated prior to the start of the study. In order to maintain examiner blinding throughout the study, the treatment provider will be a person other than the dental examiner and will exclusively provide treatment and not participate in patient assessments.', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2024-06-07