Clinical trial NCT01345292
Conditions: Dentin Sensitivity
Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Start date: 2011-04-01; Completion date: 2011-05-01
Enrollment: 226 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
This is an observer-blind, randomized, parallel-group, single-center, controlled clinical trial. Approximately 246 generally healthy adults meeting the necessary inclusion/exclusion criteria will be enrolled so that 210 subjects (70 per group) would reasonably be expected to complete the study. Subjects will have their oral soft/hard tissues assessed and will be evaluated for sensitivity levels at Screening (Visit 1), Baseline (Visit 2), Visit 3 at Week 2 and Visit 4 at Week 4. During the first two weeks of the study, subjects will be instructed to brush their teeth for one minute in their usual manner, twice daily, using the provided standard fluoride toothpaste. Subjects will return for the Baseline exam and, upon qualification with entry criteria, will be assigned to one of three treatment groups. Qualified subjects will be instructed to brush their teeth two times daily for one minute in their usual manner using the provided toothpaste (standard fluoride toothpaste or 5% potassium nitrate toothpaste). Subjects assigned to the mouthrinse group will be instructed to rinse twice daily, after brushing, with the provided mouthrinse for 60 seconds using 10 ml, for 4 consecutive weeks.

Arms: arm 1: 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 arm 2: Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste arm 3: Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste
Interventions: intervention 1: Mouthwash intervention 2: Potassium nitrate toothpaste intervention 3: Sodium fluoride toothpaste
Intervention descriptions: intervention 1: 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 intervention 2: Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste intervention 3: Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste

Protocol documents: