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A Study of the Relief of Tooth Sensitivity of an Experimental Mouthrinse Device

NCT01345292 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2015-06-10

Study results available
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Summary

This study is for people with sensitive teeth and involves going to the dentist for 4 visits over 6 weeks.

During the first 2 weeks, you will just brush your teeth two times a day with the fluoride toothpaste provided.

Then you will be assigned to a group if you qualify to continue in the study. All groups will get a marketed toothpaste and one group will also get a mouthwash with an experimental ingredient. You will have an equal chance of being assigned to any one of the three groups.

For the next 4 weeks, you will brush with your assigned toothpaste and rinse with your assigned mouthwash if assigned to the mouthwash group. A dentist will look at your mouth, teeth, tongue and gums and check for sensitive teeth. The investigators will see if the mouthwash helps to reduce tooth sensitivity during the study.

Conditions

  • Dentin Sensitivity

Interventions

DEVICE

Mouthwash

Rinse with 10 ml of the assigned mouthwash for 60 seconds after you brush in your usual manner twice daily for one minute using at least a one-inch strip of the assigned toothpaste

DRUG

Potassium nitrate toothpaste

Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste

DRUG

Sodium fluoride toothpaste

Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste

Sponsors & Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

    lead INDUSTRY

Principal Investigators

  • Michael Lynch, DMD, PhD · Johnson & Johnson Consumer and Personal Products Worldwide

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-05-31
Completion
2011-05-31

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 NCT01345292 on ClinicalTrials.gov