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Six Week Study of Experimental Mouth Rinses: Effect on Gingivitis and Plaque

NCT04921371 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2023-09-28

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of experimental mouth rinse formulations compared to a positive control mouth rinse and a hydroalcohol control mouth rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a six-week product usage period.

Conditions

  • Gingivitis
  • Plaque

Interventions

OTHER

Colgate® Cavity Protection Toothpaste

Participants will use Colgate® Cavity protection toothpaste for brushing teeth twice daily.

OTHER

Listerine® Cool Mint®

Participants will use 20 mL of Listerine® Cool Mint® mouth rinse for 30 seconds after brushing twice daily.

OTHER

Concept Curve Winter Series Toothbrush

Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.

OTHER

5% Hydroalcohol Mouthrinse

Participants will use 20 mL of 5% Hydroalcohol Mouthrinse for 30 seconds after brushing twice daily.

OTHER

Mouthrinse Prototype 1

Participants will use 20 mL of Mouthrinse Prototype 1 for 30 seconds after brushing twice daily.

OTHER

Mouthrinse Prototype 2

Participants will use 20 mL of Mouthrinse Prototype 2 for 30 seconds after brushing twice daily.

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Jeffery Milleman, DDS · Salus Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-08
Primary Completion
2019-12-19
Completion
2019-12-19

Countries

  • United States

Study Locations

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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 NCT04921371 on ClinicalTrials.gov