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

Recruiting at 1 trial location

Overseen By Jon Shea

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Gross oral pathology, Systemic diseases, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 months

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Martin Kohlmeier, MD, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Saroja Voruganti, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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.

Inclusion Criteria

I have diabetes, prediabetes, or a history of heart disease or stroke.

I can follow the study's requirements and am reachable by phone.

My gum disease is either moderate or severe, based on my dentist's findings.

Exclusion Criteria

I do not have any ongoing infections.

I have noticeable problems with my mouth or teeth.

I have mouth symptoms from conditions like pemphigus, pemphigoid, or lupus.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including periodontal treatment and measurements such as flow mediated dilation and carotid intima media thickness

1 week

1 visit (in-person)

Treatment

Participants receive regular, professional non-surgical Intensive Periodontal Therapy, with the Treatment Group receiving additional subgingival chlorhexidine irrigation

12 months

Multiple visits (in-person and remote)

Follow-up

Participants are monitored for changes in oral and systemic health, including assessments of biomarkers and emotional wellbeing

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Dental Supplies
• Periodonal Treatment
• Subgingival chlorhexidine irrigation

Trial Overview 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.

Participant Groups

Group I: Treatment Group Experimental Treatment 3 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 Group Active Control 1 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.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Colgate Palmolive

Industry Sponsor

Trials

106

Recruited

19,100+

Noel Wallace

Colgate Palmolive

Chief Executive Officer since 2019

MBA from Harvard Business School

Diana Haussling

Colgate Palmolive

Chief Marketing Officer since 2022

Bachelor's degree in Marketing