MedTrace Logo

A Clinical Trial to Test the Effect of Marketed Mouth Rinses on Decreasing Plaque and Gum Inflammation

NCT02233998 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2015-08-21

Study results available
· View outcomes & findings →

Summary

The reduction of existing plaque and gum inflammation will be evaluated using two marketed mouth rinses along with tooth brushing after 21 days of use compared to a placebo mouth rinse.

165 healthy volunteers will be enrolled in this three week study. Volunteers who qualify to be in this study will have an equal chance of being assigned to one of the three treatment groups. Volunteers will have a total of three visits including 1) Screening/Baseline Day 1 2) Day 11 (after 10 days of use) and 3) Day 22 (after 21 days of use). Volunteers will maintain a diary at home to record each treatment use and will be asked to come to the clinic without brushing or use their product for at least 8 hours, but no more than 18 hours. Examinations for oral hard/soft tissue, gingivitis, bleeding and plaque assessments will be completed at Screening/Baseline and repeated at Clinic Visit 3, which is Day 22.

Conditions

  • Plaque
  • Gingivitis

Interventions

OTHER

Mouth Rinse 1

OTHER

Mouth Rinse 2

OTHER

Mouth Rinse 3

Sponsors & Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

    lead INDUSTRY

Principal Investigators

  • Maher Naji, D.D.S · All Sum Research Center Ltd.

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Canada

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 NCT02233998 on ClinicalTrials.gov