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A Four-Week Study to Measure the Effectiveness of an Experimental Mouthwash Used After Teeth Cleaning

NCT01462110 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2020-04-07

Study results available
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Summary

This study will test the idea that using an experimental mouth rinse after each time you brush your teeth will result in a healthier mouth than using the regular mouth rinse. Participants will be expected to avoid oral hygiene (like brushing teeth or using mouthwash) for at least 12 hours before each visit and will not be allowed to eat, drink or smoke for at least 4 hours before each visit.

At the first visit, the study will be explained to you in detail and you will be allowed to ask any questions you may have before signing a consent form. You will complete a medical/dental history and the dentist will examine your mouth, during which he will poke your gums and scrape some plaque off your teeth for testing. If you do not meet the requirements to continue in the trial, you will be told that you do not need to return for more testing.

If you meet requirements to continue, you will have an equal chance of being assigned to use either of the two mouth rinses being studied. You will be given a diary, toothbrush, toothpaste, and your assigned mouth rinse, with instructions on how they must be used.

You will be instructed not to use any unassigned oral care products and to follow your usual eating habits. You will be given appointments to return two times within the next four weeks. At those visits, the staff will check to make sure you're following the instructions and ask how you're feeling, and the dentist will do the same thing he did during the first visit.

Conditions

  • Dental Plaque

Interventions

DEVICE

19416-154-1

0.15% ethyl lauroyl arginate HCl-containing mouthrinse

DEVICE

W002194-0221P

5% hydroalcohol mouthrinse

Sponsors & Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

    lead INDUSTRY

Principal Investigators

  • Marcelo Araujo, DDS, MS, PhD · Johnson & Johnson Consumer and Personal Products Worldwide

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-01
Primary Completion
2011-12-02
Completion
2011-12-02
FDA Device
Yes

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 NCT01462110 on ClinicalTrials.gov