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A Study of Experimental Mouthwashes

NCT05121909 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2023-11-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of experimental mouthwash formulations compared to a hydroalcohol control mouthwash and a positive control mouthwash 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 (R) Cavity Protection Toothpaste

Participants will use Colgate (R) Cavity Protection Toothpaste for brushing teeth twice daily.

DEVICE

Colgate (R) Cello Toothbrush

Participants will use Colgate (R) Cello Toothbrush for brushing teeth twice daily.

OTHER

Prototype 1 Mouthwash

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

OTHER

Prototype 2 Mouthwash

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

OTHER

Prototype 3 Mouthwash

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

OTHER

Listerine (R) Cool Mint (R) Antiseptic Mouthwash

Participants will use 20 mL of Listerine (R) Cool Mint (R) Antiseptic Mouthwash for 30 seconds after brushing twice daily.

OTHER

5% Hydroalcohol Mouthwash

Participants will use 20 mL of 5% Hydroalcohol Mouthwash 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
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2022-04-14
Completion
2022-04-14

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 NCT05121909 on ClinicalTrials.gov