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Non-Surgical Periodontal Treatment for Oral Health Impact on Systemic Conditions

Phase 4
Waitlist Available
Led By Martin Kohlmeier, MD, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least eighteen (18) years of age but not older than seventy (70) years of age at the time of screening
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up comparing t1 (day 90) and t4 (day 360)
Awards & highlights

Study Summary

This trial will 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.

Who is the study for?
This trial is for adults aged 18-70 with moderate to severe periodontitis and either type 2 diabetes or cardiovascular disease. Participants must have at least 16 teeth, be able to consent and follow the study protocol, have access to compatible iOS or Android devices, and not be involved in other related studies.Check my eligibility
What is being tested?
The study tests if Intensive Periodontal Therapy (deep cleaning of teeth) improves oral health and affects systemic health biomarkers. It involves around 200 participants split into a Treatment Group receiving therapy and a Control Group, using professional dental care teams.See study design
What are the potential side effects?
Potential side effects may include discomfort during treatment, tooth sensitivity post-treatment, minor bleeding from gums, possible allergic reactions to chlorhexidine irrigation if used as part of the therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I have diabetes, prediabetes, or a history of heart disease or stroke.
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I can follow the study's requirements and am reachable by phone.
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My gum disease is either moderate or severe, based on my dentist's findings.
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I am willing to take a pregnancy test if I can have children.
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I have at least 16 teeth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~comparing t1 (day 90) and t4 (day 360)
This trial's timeline: 3 weeks for screening, Varies for treatment, and comparing t1 (day 90) and t4 (day 360) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Association between changes in oral health and changes in systemic health (Flow-mediated dilation)
Association between changes in oral health and changes in systemic health (Glycated hemoglobin (HbA1c))
Impact of treatment on change in oral health measures
Secondary outcome measures
Impact of treatment on Glycated hemoglobin (HbA1c) (prediabetic and type 2 diabetic cohorts)
Impact of treatment on beliefs about periodontal disease
Impact of treatment on bleeding on probing
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment GroupExperimental Treatment3 Interventions
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 II: Control GroupActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,498 Previous Clinical Trials
4,176,012 Total Patients Enrolled
Colgate PalmoliveIndustry Sponsor
86 Previous Clinical Trials
17,218 Total Patients Enrolled
Martin Kohlmeier, MD, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Media Library

Periodonal Treatment Clinical Trial Eligibility Overview. Trial Name: NCT04954313 — Phase 4
Cardiovascular Disease Research Study Groups: Treatment Group, Control Group
Cardiovascular Disease Clinical Trial 2023: Periodonal Treatment Highlights & Side Effects. Trial Name: NCT04954313 — Phase 4
Periodonal Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT04954313 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what contexts is Periodonal Treatment regularly utilized?

"As a general practice, periodontal treatment is utilized to eliminate bacteria and cure infections. Additionally, it can be applied to treat throat injuries and pressure sores."

Answered by AI

What primary objectives are being sought through this research endeavor?

"This clinical trial will run for 360 days, with the primary objective of determining a relationship between changes in oral health and systemic effects (measured by Flow-mediated dilation). Secondary aims include assessing any shifts in Glycated hemoglobin levels among prediabetic or type 2 diabetic patients, gauging whether periodontal probing results have changed after treatment, and analysing patient beliefs surrounding periodontal disease through use of the Protective Motivation Theory questionnaire."

Answered by AI

Is this research venture open to new participants?

"This medical trial is presently in search of participants, as evidenced by clinicaltrials.gov which indicates that this experiment was put on the site on September 28th 2021 and updated for last time on July 18th 2022."

Answered by AI

Has the FDA certified Periodonal Treatment as a safe and effective treatment?

"There is ample evidence to suggest that Periodontal Treatment can be used safely, so Power's team gave it a score of 3."

Answered by AI

How many participants are engaged with this clinical trial?

"Affirmative. Clinicaltrials.gov states that this clinical trial, which went public on September 28th 2021, is currently admitting enrollees. 200 people must be recruited from 2 diverse locations for the study to reach completion."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
UNC Nutrition Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~50 spots leftby Feb 2025