Baseline Oral Health Study: UnCoVer the Connections to General Health

University of North Carolina (UNC)

Status and phase: Completed; Phase 4

Conditions: Cardiovascular Diseases; Diabetes Type 2

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04954313

21-1453

CRO-2020-03-VERILY-LK (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 186 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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186 participants in 2 patient groups

Treatment Group

Experimental group

Description:

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.

Treatment:

Drug: Subgingival chlorhexidine irrigation

Other: Periodonal Treatment

Other: Dental Supplies

Control Group

Active Comparator group

Description:

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.

Treatment:

Other: Periodonal Treatment