Oral Health Program for Type 2 Diabetes

Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Colgate Palmolive
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special program focused on oral health can impact dental care needs in people with Type 2 Diabetes. The goal is to determine if a behavioral intervention, known as the Diabetes Oral Health Program, can reduce the number of dental treatments and claims among participants. Individuals diagnosed with Type 2 Diabetes who speak English and are open to receiving text messages and participating in online activities might be a good fit for this study. As a Phase 4 trial, this study involves an FDA-approved program and aims to understand how it can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for the treatments in this trial?

Research has shown that the ingredients cetylpyridinium chloride and zinc lactate, found in mouthwashes, are generally safe and well-tolerated. Studies have found that these ingredients help reduce plaque and gum disease without causing major side effects. However, frequent use of similar mouthwashes has been linked to a higher risk of developing diabetes in some people, so awareness of this is important.

Research also considers stannous fluoride, commonly found in toothpaste, to be safe. It effectively treats gum inflammation and reduces tooth sensitivity, with no major side effects reported. Both treatments are widely used and have a strong safety record for oral health.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Diabetes Oral Health Program because it takes a unique approach by focusing on oral health to manage Type 2 Diabetes. Unlike standard treatments that primarily target blood sugar levels with medications like metformin or insulin, this program addresses the link between oral health and diabetes control. By potentially reducing inflammation and improving gum health, this method might enhance overall diabetes management, offering a holistic adjunct to traditional treatments.

What evidence suggests that this trial's treatments could be effective for Type 2 Diabetes?

Research has shown that people with Type 2 diabetes often experience oral health problems, such as gum disease and tooth loss. Studies have found that a mouthwash containing Cetylpyridinium Chloride (CPC) and Zinc can reduce gum inflammation and plaque by more than 20%. This mouthwash also decreases harmful oral bacteria. Additionally, regular use of toothpaste with Stannous Fluoride can improve gum health, reduce harmful bacteria, and decrease gum inflammation. These findings suggest that these treatments can enhance oral health in people with Type 2 diabetes.24678

Are You a Good Fit for This Trial?

This trial is for adults with Type 2 diabetes who may also have gum disease or cavities. Participants should be able to follow an oral health program and use mouthwash and toothpaste as directed.

Inclusion Criteria

English speaking
I am 18 years old or older.
Consented to participation in the Fidelis Care Diabetes Care program
See 2 more

Exclusion Criteria

Severe cognitive impairment
Self-reported pregnant
I have type 1 diabetes.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a behavioral intervention aimed at improving oral health

12 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cetylpyridinium Chloride (CPC) and Zinc Lactate Mouthwash
  • Diabetes Oral Health Program
  • Stannous Fluoride Dentifrice

Trial Overview

The study tests whether a special oral health education program, along with using a CPC and zinc lactate mouthwash and stannous fluoride toothpaste, can improve dental health in people with Type 2 diabetes.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Type 2 DiabetesExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Colgate Palmolive

Lead 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

Evaluate the Efficacy of an Oral Health Behavioral ...

The purpose of this clinical study is to evaluate the effect of a behavioral intervention on the number of preventive and treatment dental ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41627982/

Impact of Cetylpyridinium Chloride and Zinc Mouthwash on ...

Clinical trials have validated the efficacy of CPC and zinc lactate in enhancing oral health metrics, although the long-term impact of their combined use on ...

Impact of Cetylpyridinium Chloride and Zinc Mouthwash on ...

The groups that were treated with CPC + Zn mouthwash had a 20.6% and 21.5% greater reduction in whole-mouth gingivitis and a 27.4% and 25.3% ...

Antibacterial Effects of a Cetylpyridinium Chloride and Zinc ...

The cetylpyridinium chloride and zinc lactate mouthwash demonstrated rapid reductions in bacterial viability with additional effects on reducing microbial acid

Antiplaque and antigingivitis efficacy of cetylpyridinium ...

The authors of this study aimed to evaluate the clinical antiplaque and antigingivitis effects of 3 oral hygiene regimens: toothbrushing with standard ...

Over-the-counter mouthwash use and risk of pre-diabetes ...

Frequent regular use of over-the-counter mouthwash was associated with increased risk of developing pre-diabetes/diabetes in this population.

Mouthwash Containing Cetylpyridinium Chloride and Zinc ...

Cetylpyridinium chloride (CPC) is a well-known antibacterial for use in mouthwash formulas, demonstrated to successfully reduce plaque and ...

Efficacy of regular gargling with a cetylpyridinium chloride plus ...

CPC+Zn are antiseptic components present in mouthwashes, which are safe to use and have demonstrated excellent antiplaque and antigingivitis ...