NCT01133379

Tooth Sensitivity Relief by Two Mouthrinses

Evaluation of the Efficacy of Two Potassium Oxalate Containing Mouthrinses for Relieving Dentinal Hypersensitivity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is for people with sensitive teeth and involves going to the dentist for 6 visits over 8 weeks. During the first 2 weeks, everyone will just brush their teeth two times a day with the fluoride toothpaste provided. Then you will be assigned to a mouthwash group if you qualify to continue in the study. Two groups will get mouthwash with a certain amount of an experimental ingredient and one group will get a mouthwash with no experimental ingredients. You will have an equal chance of being assigned to any one of the three groups. For the next 6 weeks, you will rinse with your assigned mouthwash after brushing. 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 a double-blind, randomized, parallel group, single center, controlled clinical trial design. Approximately 200 generally healthy adults meeting the necessary inclusion/exclusion criteria will be enrolled so that 180 subjects (60 per treatment 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), Week 1, Week 2, Week 4 \& Week 6. 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 standard fluoride toothpaste. Subjects will be instructed to rinse twice daily, after brushing, with the provided mouthrinse for 60 seconds using 10 ml or 20 ml (depending on the treatment group), for 6 consecutive weeks.

Conditions

• Dentin Sensitivity

Interventions

Type	Name	Description
DEVICE	12027-019	Rinse with 10 mL for 60 seconds twice daily after brushing in your usual manner for 1 minute using at least a one-inch strip of the assigned toothpaste.
DEVICE	12027-020	Rinse with 20 mL for 60 seconds twice daily after brushing in your usual manner for 1 minute using at least a one-inch strip of the assigned toothpaste.
DEVICE	12027-021	Rinse with 10 mL for 60 seconds twice daily after brushing in your usual manner for 1 minute using at least a one-inch strip of the assigned toothpaste

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-05-28
• Last updated: 2015-07-09
• Results posted: 2015-07-09

Locations

1 site across 1 country: United States