Phase 4 N=155 Randomized Double-blind Prevention

Baseline Oral Health Study: UnCoVer the Connections to General Health

Cardiovascular Diseases · Diabetes Type 2

Bottom Line

View on ClinicalTrials.gov: NCT04954313 ↗

Enrolled (actual)

155

Serious AEs

0.7%

Results posted

Feb 2026

Primary outcome: Primary: Impact of Treatment on Change in Oral Health Measures — 0.186; 0.190 millimeters (probing depth difference) — p=0.957

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Subgingival chlorhexidine irrigation (Drug); Dental Supplies (Other); Periodonal Treatment (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Feb 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Impact of Treatment on Change in Oral Health Measures	0.186; 0.190	0.957
PRIMARY Association Between Changes in Oral Health (Probing Depth) and Changes in Systemic Health (HbA1c)	-0.093; -0.282	0.0378 sig
PRIMARY Association Between Changes in Oral Health and Changes in Systemic Health (Flow-mediated Dilation)	-0.0528; 0.006	0.4735
SECONDARY Change in Emotional Wellbeing	1.25; -0.6	0.469
SECONDARY Change in Beliefs About Periodontal Disease	2.56; -0.60	0.220
SECONDARY Change in Bleeding on Probing	-0.109; -0.212	0.014 sig
SECONDARY Change in Gingival Index	-0.154; -0.379	0.025 sig
SECONDARY Percent Change in Clinical Attachment Level (CAL)	-0.31; 0.90	0.79
SECONDARY Change in Dental Plaque Index	-0.090; -0.181	0.394
SECONDARY Change in Flow-mediated Dilation	-0.488; 0.45	0.323
SECONDARY Percent Change in Glycated Hemoglobin (HbA1c) (Prediabetic and Type 2 Diabetic Cohorts)	-0.99; -0.65	0.464
SECONDARY Percent Change in Carotid Intima Media Thickness (IMT)	2.76; 3.48	0.838
SECONDARY Percent Change of High Sensitivity C-reactive Protein (Hs-CRP)	-8.56; 21.8	0.242
SECONDARY Percent Change in Total Cholesterol	-0.0554; -0.710	0.847
SECONDARY Percent Change in Low Density Lipoprotein (LDL) Cholesterol	2.63; -0.033	0.666
SECONDARY Percent Change in Triglycerides	-2.86; -1.52	0.758

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04954313). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.