N/A
N=226
A Study of the Relief of Tooth Sensitivity of an Experimental Mouthrinse Device
Dentin Sensitivity
Bottom Line
View on ClinicalTrials.gov: NCT01345292 ↗Enrolled (actual)
226
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Mean Tactile Sensitivity Score at Week 4 — 10.39; 21.83; 18.72 grams of force — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mouthwash (Device); Potassium nitrate toothpaste (Drug); Sodium fluoride toothpaste (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Tactile Sensitivity Score at Week 4 |
10.39; 21.83; 18.72 | <0.001 sig |
| PRIMARY Mean Tactile Sensitivity Score at Week 2 |
10.10; 13.16; 12.51 | <0.001 sig |
| SECONDARY Mean Tactile Sensitivity Visual Analog Scale (VAS) Score at Week 2 |
41.59; 39.52; 37.16 | 0.324 |
| SECONDARY Mean Tactile Sensitivity VAS Score at Week 4 |
39.49; 30.94; 29.32 | <0.001 sig |
| SECONDARY Mean Cold Air Stimulus VAS Score at Week 2 |
43.65; 38.74; 40.22 | 0.032 sig |
| SECONDARY Mean Cold Air Stimulus VAS Score at Week 4 |
39.54; 28.36; 29.30 | <0.001 sig |
| SECONDARY Global Subjective VAS Score at Week 2 |
44.94; 43.68; 43.64 | 0.533 |
| SECONDARY Global Subjective VAS Score at Week 4 |
41.32; 32.79; 35.19 | <0.001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Males and females at least 18 years of age in good general and oral health without any known allergy to commercial dental products or cosmetics.
- Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial.
- Willingness to use the assigned products according to instructions, availability for appointments, and likelihood of completing the clinical trial.
- The appropriate number and location of eligible teeth, based on protocol-defined standards.
- Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect).
Exclusion Criteria
- Any medical or dental history or condition, or use of any medication or drug, that per protocol or in the opinion of the investigator might compromise subject comfort or safety, or the analysis of study results.
- Volunteers who have been using any of the following within protocol-defined timeframes:
- home-care bleaching, whitening products or professional bleaching treatment
- desensitizing agents whether prescribed or over-the-counter
- sensitivity toothpastes, mouthwash or oral care products used for the treatment of dentinal hypersensitivity
- Women who are pregnant, nursing or plan to become pregnant during the course of the study.
Data sourced from ClinicalTrials.gov (NCT01345292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.