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NCT01727258
Evaluation of an Experimental Mouth Rinse Device for Relieving Dentinal Hypersensitivity
NA trial testing Mouth Rinse in Dentin Sensitivity in 153 participants. Completed in 1 February 2013.
1 February 2013
Quick facts
| Lead sponsor | Johnson & Johnson Consumer and Personal Products Worldwide |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Enrollment | 153 |
| Start date | 1 December 2012 |
| Primary completion | 1 February 2013 |
| Estimated completion | 1 February 2013 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Mouth Rinse — full drug profile →
- Fluoride Toothpaste — full drug profile →
- Potassium Nitrate Toothpaste
Conditions studied
- Dentin Sensitivity — all drugs for Dentin Sensitivity →
Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide — full company profile →
Who can join
18 and older, any sex, with Dentin Sensitivity. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Mean Tactile Sensitivity Score at Week 4
Time frame: 4 weeks
Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. -
Mean Tactile Sensitivity Score at Week 2
Time frame: 2 weeks
Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.
Sponsor's own description
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 subjects, and check for sensitive teeth. During the first 2 weeks, participants will brush their teeth two times a day with the fluoride toothpaste provided. Then, if they qualify to continue in the study, participants will be assigned to a treatment group. All the groups will get toothpaste currently sold on the market, and one group will get a mouthwash with an experimental ingredient to use as well. Subjects will have an equal chance of being assigned to any one of the three groups. For the next 4 weeks, subjects will use their assigned products according to the directions provided. At Visit 1 subjects will be supervised while they brush their teeth to ensure they understand the directions. They will also have supervised use of the product at Visit 2. We will see if the mouthwash helps to reduce tooth sensitivity during the study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01727258
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Dentin Sensitivity
Currently open trials in the same condition.
- NCT06463938 — A Clinical Trial to Compare Lasotronix Alone or in Combination With CPP-ACP to Treat DH · NA · recruiting
Other Johnson & Johnson Consumer and Personal Products Worldwide trials
Trials by the same sponsor.
- NCT06798441 — Determination of the Oral Irritation Potential of a Fluoride Rinse in Children · NA · completed
- NCT06479096 — Four-Week Oral Malodor and Clinical Safety for a Concentrated Cosmetic Mouthwash · NA · completed
- NCT07028671 — Exploratory Investigation of Motilium's Effectiveness and Safety for the OTC Treatment of Dyspepsia-related Symptoms · completed
- NCT03213353 — A Bioequivalence Study Between Two Brands of Medications to Treat Cough & Cold Symptoms · Phase 1 · completed
- NCT03041064 — Multiday Beach Study · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01727258 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Johnson & Johnson Consumer and Personal Products Worldwide
- Last refreshed: 8 June 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01727258.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing