Baseline Oral Health Study: UnCoVer the Connections to General Health

NCT04954313 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 21-1453CRO-2020-03-VERILY-LK
• Study Type: interventional
• Target: 786
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cardiovascular Diseases; Diabetes Type 2

Keywords

Oral health

Outcome Measures

Primary Outcomes (3)

• Impact of Treatment on Change in Oral Health Measures

  The impact of treatment on oral health measures, will be performed using generalized estimating equations (GEE) methods. Longitudinal outcomes in the Treated vs. Control groups will be compared and will include all subjects who were randomized and their data from visits T1 - T4 based on intent-to-treat (ITT) group assignment. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health.

  Comparing T1 (day 90) and T4 (day 360)

• Association Between Changes in Oral Health (Probing Depth) and Changes in Systemic Health (HbA1c)

  The association between changes in oral health and changes in systemic health, will be evaluated using correlation analysis. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health. The correlation between % change in whole-mouth mean probing depth and % change in HbA1c will be determined in subjects with prediabetes or type 2 diabetes at screening.

  Comparing T0 (day 0) and T4 (day 360)

• Association Between Changes in Oral Health and Changes in Systemic Health (Flow-mediated Dilation)

  The association between changes in oral health and changes in systemic health, will be evaluated using correlation analysis. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health. The correlation between % change in whole-mouth mean probing depth and change in flow-mediated dilation will be calculated.

  Comparing T0 (day 0) and T4 (day 360)

Secondary Outcomes (13)

• Change in Emotional Wellbeing

  Comparing T0 (day 0) and T4 (day 360)

• Change in Beliefs About Periodontal Disease

  Comparing T0 (day 0) and T4 (day 360)

• Change in Bleeding on Probing

  Comparing T0 (day 0) and T4 (day 360)

• Change in Gingival Index

  Comparing T0 (day 0) and T4 (day 360)

• Percent Change in Clinical Attachment Level (CAL)

  Comparing T0 (day 0) and T4 (day 360)

Study Arms (2)

Treatment Group

EXPERIMENTAL

The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.

Drug: Subgingival chlorhexidine irrigation; Other: Dental Supplies; Other: Periodonal Treatment

Control Group

ACTIVE COMPARATOR

The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP). Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.

Other: Periodonal Treatment

Interventions

Subgingival chlorhexidine irrigation DRUG

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).

Treatment Group

Dental Supplies OTHER

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.

Treatment Group

Periodonal Treatment OTHER

Initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planing (SRP).

Control Group; Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Colgate Palmolive: collaborator

Study Sites (2)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

UNC Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Saroja Voruganti, PhD
• Organization: University of North Carolina at Chapel Hill

saroja@unc.edu

704 250-5009

Study Officials

• Saroja Voruganti, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 8, 2021
• Study Start: September 28, 2021
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 12, 2026
• Results First Posted: February 12, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 to 36 months following publication
• Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (2)