Baseline Oral Health Study: UnCoVer the Connections to General Health
Status:
Recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
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.