MedTrace Logo

A Study of Mouth Rinses in Type 1 and Type 2 Diabetic Participants

NCT04449952 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2023-08-07

No results posted yet for this study

Summary

The purpose of this study is to evaluate mouth rinse formulations for oral soft tissue tolerance and efficacy in plaque/ gingivitis prevention/reduction in Type 1 and Type 2 diabetics when used twice daily as an adjunct to tooth brushing during a twelve-week treatment period.

Conditions

  • Gingivits in Diabetics

Interventions

OTHER

Listerine Cool Mint

Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing

OTHER

5% Hydroalcohol Mouth Rinse

Participants use 20 mL of 5% Hydroalcohol mouth rinse for 30 sec after brushing.

OTHER

Colgate Cavity Protection Toothpaste

Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.

OTHER

Alcohol-Free Essential Oil Containing (AFEO) Mouth Rinse Lead Formula

Participants use 20 mL of AFEO mouth rinse lead formula for 30 sec after brushing.

DEVICE

Concept Curve Winter Series Toothbrush

Participants will brush teeth at least one minute with provided bristled toothbrush.

DEVICE

Listerine Cool Mint Floss

Participants will use marketed fluoride-containing dentifrice, floss.

Sponsors & Collaborators

  • Johnson & Johnson Consumer Inc. (J&JCI)

    lead INDUSTRY

Principal Investigators

  • Jeffery Milleman · Salus Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-02
Primary Completion
2020-03-06
Completion
2020-03-06

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04449952 on ClinicalTrials.gov