Baseline Oral Health Study: UnCoVer the Connections to General Health

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Colgate Palmolive
• Treatments: Chlorhexidine

Criteria

Inclusion Criteria:

• Enrolled in the Verily's Project Project Baseline Health Study

• At least 18 years of age

• 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 a history of at least one of the following indications of cardiometabolic disease:

• Type 2 diabetes: 9% ≥ HbA1c ≥ 6.5% OR medical history of Type 2 diabetes

• Prediabetes: 6.4% > HbA1c > 5.7% OR

• Cardiovascular Disease (CVD):

• A past coronary calcium score (CCS) of > 100 OR

• Medical history of Myocardial Infarction, Coronary Artery Disease or stroke

• Has a history of hsCRP level of > 1 mg/L

• 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:

• 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 Oral Health study