A Study of the Relief of Tooth Sensitivity of an Experimental Mouthrinse Device
Assessment of a Potassium Oxalate-Containing Formulation for the Relief of Dentinal Hypersensitivity
1 other identifier
interventional
226
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Posted
Study publicly available on registry
May 2, 2011
CompletedResults Posted
Study results publicly available
June 10, 2015
CompletedJune 10, 2015
June 1, 2015
1 month
April 28, 2011
May 20, 2015
June 8, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Mean Tactile Sensitivity Score at Week 4
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.
4 weeks
Mean Tactile Sensitivity Score at Week 2
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.
2 weeks
Secondary Outcomes (6)
Mean Tactile Sensitivity Visual Analog Scale (VAS) Score at Week 2
2 weeks
Mean Tactile Sensitivity VAS Score at Week 4
4 weeks
Mean Cold Air Stimulus VAS Score at Week 2
2 weeks
Mean Cold Air Stimulus VAS Score at Week 4
4 weeks
Global Subjective VAS Score at Week 2
2 weeks
- +1 more secondary outcomes
Study Arms (3)
12027-027
EXPERIMENTALRinse 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
310158077046
ACTIVE COMPARATORBrush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste
037000003212
PLACEBO COMPARATORBrush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste
Interventions
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
Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste
Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BioSci Research America, Inc.
Las Vegas, Nevada, 89121, United States
Related Publications (1)
Sharma D, McGuire JA, Gallob JT, Amini P. Randomised clinical efficacy trial of potassium oxalate mouthrinse in relieving dentinal sensitivity. J Dent. 2013 Jul;41 Suppl 4:S40-8. doi: 10.1016/S0300-5712(13)70005-8.
PMID: 23929644DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael Lynch, DMD, PhD/Study Director
- Organization
- Johnson & Johnson Consumer and Personal Products Worldwide
Study Officials
- STUDY DIRECTOR
Michael Lynch, DMD, PhD
Johnson & Johnson Consumer and Personal Products Worldwide
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2011
First Posted
May 2, 2011
Study Start
April 1, 2011
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
June 10, 2015
Results First Posted
June 10, 2015
Record last verified: 2015-06