Clinical trial NCT04954313: Baseline Oral Health Study: UnCoVer the Connections to General Health
Official title: Baseline Oral Health Study: UnCoVer the Connections to General Health
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Cardiovascular Diseases
Diabetes Type 2
Keywords: Oral health
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Colgate Palmolive
First posted: 2021-07-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

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)

Primary outcomes:
measure: Impact of treatment on change in oral health measures
timeFrame: Comparing T1 (day 90) and T4 (day 360)
measure: Association between changes in oral health and changes in systemic health (Glycated hemoglobin (HbA1c))
timeFrame: Comparing baseline (day 0) and T4 (day 360)
measure: Association between changes in oral health and changes in systemic health (Flow-mediated dilation)
timeFrame: Comparing baseline (day 0) and T4 (day 360)
Secondary outcomes:
measure: Impact of treatment on emotional wellbeing
timeFrame: Comparing baseline (day 0) and T4 (day 360)
measure: Impact of treatment on beliefs about periodontal disease
timeFrame: Comparing baseline (day 0) and T4 (day 360)
measure: Impact of treatment on bleeding on probing
timeFrame: Comparing baseline (day 0) and T4 (day 360)
measure: Impact of treatment on gingival index
timeFrame: Comparing baseline (day 0) and T4 (day 360)
measure: Impact of treatment on clinical attachment level
timeFrame: Comparing baseline (day 0) and T4 (day 360)
measure: Impact of treatment on dental plaque index
timeFrame: Comparing baseline (day 0) and T4 (day 360)
measure: Impact of treatment on flow-mediated dilation
timeFrame: Comparing baseline (day 0) and T4 (day 360)
measure: Impact of treatment on Glycated hemoglobin (HbA1c) (prediabetic and type 2 diabetic cohorts)
timeFrame: Comparing baseline (day 0) and T4 (day 360)
measure: Impact of treatment on carotid intima media thickness (IMT)
timeFrame: Comparing baseline (day 0) and T4 (day 360)
measure: Impact of treatment on high sensitivity C-reactive protein (hs-CRP)
timeFrame: Comparing baseline (day 0) and T4 (day 360)
measure: Impact of treatment on total cholesterol
timeFrame: Comparing baseline (day 0) and T4 (day 360)
measure: Impact of treatment on low density lipoproteins (LDL) cholesterol
timeFrame: Comparing baseline (day 0) and T4 (day 360)
measure: Impact of treatment on triglycerides
timeFrame: Comparing baseline (day 0) and T4 (day 360)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Kannapolis
country: United States
facility: UNC Nutrition Research Institute
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Saroja Voruganti, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Martin Kohlmeier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: