Baseline Oral Health Study: UnCoVer the Connections to General Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-28

Study Completion Date

2025-02-01

Brief Summary

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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.

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Detailed Description

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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

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Cardiovascular Diseases Diabetes Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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Treatment Group

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.

Group Type EXPERIMENTAL

Subgingival chlorhexidine irrigation

Intervention Type 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).

Dental Supplies

Intervention Type 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.

Periodonal Treatment

Intervention Type OTHER

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

Control Group

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.

Group Type ACTIVE_COMPARATOR

Periodonal Treatment

Intervention Type OTHER

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

Interventions

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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).

Intervention Type DRUG

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.

Intervention Type OTHER

Periodonal Treatment

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

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No