CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 375 enrolled
Drug / intervention
Experimental Mouth Rinse 12027-033 +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02113579
NCT02113579N/ACompleted

Assessment of a Potassium Oxalate Containing Formulation for the Relief of Dentinal Hypersensitivity

Johnson & Johnson Consumer and Personal Products Worldwide·interventional·Posted Apr 14, 2014·Updated Jun 10, 2015

In Brief

A clinical study evaluating Experimental Mouth Rinse 12027-033 and Placebo Mouth Rinse for Dentin Sensitivity. Completed, enrolled 375 participants across 2 sites.

Detailed Summary

This study is for people with sensitive teeth and involves going to the dentist for 4 visits over 6 weeks. At each visit the dentist will look at the mouth, teeth, tongue and gums of participants, and check for sensitive teeth. During the first 2 weeks, participants will brush their teeth 2 times a day with the fluoride toothpaste provided. Then, if they qualify to continue in the study, participants will be assigned to one of two treatment groups for the last 4 weeks. Both groups will use assigned toothpaste currently sold on the market. Both groups will each have an investigative mouth rinse to use as well. Participants will have an equal chance of being assigned to any one of the three groups. For the next 4 weeks, participants will use their assigned products according to the directions provided. At Visit 1, participants will be supervised while they brush their teeth to ensure they understand the directions. They will also have supervised use of the products at Visit 2. Results will be analyzed to assess whether the mouthwashes help to reduce tooth sensitivity during the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 14, 2014
Enrollment StartMar 1, 2014
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.2 years ago

Interventions

Experimental Mouth Rinse 12027-033device

After brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily.

Placebo Mouth Rinseother

After brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily.