Last updated: 11/04/2018 10:27:08
Investigating the Efficacy of a Dentifrice in Providing Long Term Relief from Dentinal Hypersensitivity
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Long Term Relief from Dentinal Hypersensitivity
Trial description: Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice daily brushing of a toothpaste containing stannous fluoride in comparison to marketed (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Mean change from Baseline in Schiff sensitivity score
Timeframe: Baseline-Week 8
Secondary outcomes:
Mean change from Baseline in Schiff sensitivity score
Timeframe: Baseline-Week 4
Mean change from Baseline in Tactile sensitivity
Timeframe: Baseline-Week 8
Mean change from Baseline in Tactile sensitivity
Timeframe: Baseline-Week 4
Mean change in Dentinal Hypersensitivity after 4 weeks as measured by Visual Analog Scale (VAS)
Timeframe: Baseline-Week 4
Mean change in Dentinal hypersensitivity after 8 weeks as measured by Visual Analog Scale (VAS)
Timeframe: Baseline - Week 8
Interventions:
Drug: Stannous fluoride
Drug: Sodium monofluorophosphate
Enrollment:
119
Observational study model:
Not applicable
Primary completion date:
2013-31-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dentine Hypersensitivity
Product
Not applicable
Collaborators
Not applicable
Study date(s)
February 2013 to May 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Participants with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.
- Participants with minimum of 20 natural teeth.
- Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
- Any condition which, in the opinion of the investigator, causes dry mouth.
Inclusion and exclusion criteria
Inclusion criteria:
- Participants with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.
- Participants with minimum of 20 natural teeth.
- At screening, a minimum of two accessible teeth (incisors, canines, premolars) that meet all of the following criteria. a) Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. b) Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1. c) Teeth that are determined to be sensitive by the subject following a 1 second air blast to the cervical margin.
Exclusion criteria:
- Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
- Any condition which, in the opinion of the investigator, causes dry mouth.
- Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.
- Participant using of a desensitising dentifrice within 6 weeks of screening
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2013-31-05
Actual study completion date
2013-31-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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