NCT04954313

Baseline Oral Health Study: UnCoVer the Connections to General Health

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 786 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Subgingival chlorhexidine irrigation	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).
OTHER	Dental Supplies	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.
OTHER	Periodonal Treatment	Initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planing (SRP).

Timeline

• Start date: 2021-09-28
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2021-07-08
• Last updated: 2026-02-12
• Results posted: 2026-02-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study