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Deep clean teeth to tame heart disease and diabetes?

NCT ID NCT04954313

Disease control Sponsor: University of North Carolina, Chapel Hill Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether intensive dental cleaning and oral hygiene advice can improve gum health and also affect markers of heart disease and type 2 diabetes. About 200 adults with gum disease and either heart disease or diabetes (or prediabetes) took part. Researchers measured changes in gum pocket depths and linked them to changes in blood sugar and blood vessel function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

786 people

The number who actually took part.

Started

Sep 2021

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder periodontitis prediabetes syndrome type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases Diabetes type 2

Contacts and locations

Locations

  • UNC Nutrition Research Institute

    Kannapolis, North Carolina, 28081, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.