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

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Intensive Periodontal Therapy, a special dental cleaning, affects oral health and overall health indicators related to heart disease and type 2 diabetes. The therapy includes regular cleanings and subgingival chlorhexidine irrigation, a germ-fighting rinse, to determine if it improves health markers in the body. Suitable candidates for this trial have moderate to severe gum disease, at least 16 teeth, and are managing conditions like type 2 diabetes or heart disease. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, allowing researchers to understand its benefits for more patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What is the safety track record for these treatments?

A previous study found non-surgical gum treatment to be safe and easy to handle. It improves oral health and reduces related health issues. This treatment has been used for a long time and is a common method to enhance gum health.

Research shows that rinsing under the gums with chlorhexidine effectively reduces gum swelling and plaque. Studies indicate it is generally safe in dental care, helping control gum disease without major side effects.

Both treatments are widely used and have a good safety record. They are integral to regular dental practices aimed at improving oral health. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores the potential systemic health benefits of advanced periodontal care. Unlike traditional periodontal treatments which typically focus on scaling and root planing (SRP) alone, this approach includes subgingival chlorhexidine irrigation, which targets bacteria below the gum line more effectively. Additionally, it combines behavioral advice from dental professionals to boost patient motivation and oral health maintenance. This comprehensive method could not only improve oral health but also have positive effects on overall health, like reducing inflammation and improving cardiovascular markers.

What evidence suggests that this trial's treatments could be effective for improving oral health and systemic conditions?

Research has shown that non-surgical treatments for gum disease, such as scaling and root planing, effectively improve oral health. These treatments reduce gum swelling and control plaque, which are crucial for managing gum disease. For individuals with other health issues, like heart disease or diabetes, this treatment has also been linked to better overall health.

In this trial, participants in the Treatment Group will receive subgingival chlorhexidine irrigation, which involves rinsing under the gums with a germ-killing liquid, in addition to standard periodontal treatment. Studies indicate that this method can significantly decrease gum bleeding and swelling. Combining both treatments shows promise for improving oral health and may also benefit overall health. ^{1 2 6 7 8}

Who Is on the Research Team?

Saroja Voruganti, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32594621/

Non-surgical periodontal therapy effectively improves ... Non-surgical periodontal therapy is a gold standard approach towards improving patient-based outcomes, reducing co-morbidities and enhancing patient safely.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10751251/

Systematic review and meta-analysis of randomized ... These findings suggest that NSPT is also an effective procedure in managing periodontitis in patients with concurrent systemic conditions.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0749379714001536

Evidence from Insurance Data for Five Systemic Conditions These cost-based results provide new, independent, and potentially valuable evidence that simple, noninvasive periodontal therapy may improve health outcomes.

4. mdpi.com mdpi.com/2227-9032/12/14/1430

Impact of Nonsurgical Periodontal Treatment ... The overall success rate was 74.0%, with anterior teeth exhibiting the lowest number of residual pockets (n = 55, 13.7%) followed by premolars ( ...

5. bmcoralhealth.biomedcentral.com bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-025-06595-x

Management of periodontitis by three different approaches to ... All three treatment approaches were effective in reducing PS, BS, and PD in patients with periodontitis, while FMDeb and FMDis protocols ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1882761625000134

Efficacy of adjunctive periodontal interventions in non- ... This study evaluates the effectiveness of adjunctive therapies combined with non-surgical periodontal treatment for Stage III/IV Grade C periodontitis, ...

7. bmcoralhealth.biomedcentral.com bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-021-02001-4

Patient-reported experiences and outcomes following two ... Evaluation of the effect of non-surgical periodontal treatment on oral health-related quality of life: estimation of minimal important ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05880303

Effect of Nonsurgical Periodontal Therapy (NSPT) on ... DAS28 score is a measure of RA disease activity in RA subjects. Researchers demonstrated that non-surgical periodontal therapy led to improvements of DAS28 ...