A Twelve Week Study of Experimental Mouth Rinses

NCT05120141 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-06-29

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 hydroalcohol control mouth rinse and a positive control mouth rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a twelve-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

American Dental Association (ADA) Ref Toothbrush

Participants will use soft bristled Toothbrush for brushing teeth twice daily.

OTHER

Prototype 1 Mouth Rinse

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

OTHER

Prototype 2 Mouth Rinse

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

OTHER

Prototype 3 Mouth Rinse

Participants will use 20 mL of Prototype 3 Mouth Rinse for 30 seconds after brushing twice daily.

OTHER

Listerine Cool Mint Mouth Rinse

Participants will use 20 mL of Listerine Cool Mint Mouth Rinse for 30 seconds after brushing twice daily.

OTHER

Hydroalcohol Mouth Rinse

Participants will use 20 mL of Hydroalcohol Mouth Rinse for 30 seconds after brushing twice daily.

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Chhaju Ram Goyal, DDS · All Sum Research Center Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-29
Primary Completion
2021-07-23
Completion
2021-07-23

Countries

  • Canada

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 NCT05120141 on ClinicalTrials.gov