Last updated: 11/07/2018 12:27:49
The efficacy of a dentifrice in providing relief from immediate and short 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 immediate and short term relief from dentinal hypersensitivity
Trial description: A randomised, examiner blind, two treatment arm, stratified, parallel design, single-site study in subjects with at least two sensitive teeth to compare the efficacy of a test dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change From Baseline in Schiff Sensitivity Score on Day 14
Timeframe: Baseline, Day 14
Secondary outcomes:
Change From Baseline in Schiff Sensitivity Score on Post First Brushing (after 5 minutes) and Day 3
Timeframe: Baseline, post first brushing (after 5 minutes) and Day 3
Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (after 5 minutes), Day 3 and Day 14
Timeframe: Baseline, post first brushing (after 5 minutes), Day 3 and Day 14
Interventions:
Drug: Stannous Fluoride
Drug: Sodium Monofluorophosphate
Enrollment:
120
Observational study model:
Not applicable
Primary completion date:
2012-12-06
Time perspective:
Not applicable
Clinical publications:
Am. J Dent. 2016; 29(1): 25-32.
Medical condition
Dentine Hypersensitivity
Product
SKF46655, SKF46656
Collaborators
Not applicable
Study date(s)
March 2012 to June 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Inclusion
- Demonstrates understanding of the study and willingness to participate
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion
- Demonstrates understanding of the study and willingness to participate
- Aged at least 18 to 65 years
- Understands and is willing, able and likely to comply with all study procedures and restrictions
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination.
- Self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years
- Minimum of 20 natural teeth at screening, a minimum of two accessible teeth (incisors, canines, pre-molars)
- At baseline, participant has two non-adjacent sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity measured by tactile stimulus (Yeaple ≤ 20g) and evaporative (air) assessment (Schiff Sensitivity Score ≥ 2) at baseline Exclusion
- Pregnant or breast-feeding women
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
- Recent history (within the last year) of alcohol or other substance abuse
- An employee of the sponsor or the study site or members of their immediate family
- 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 xerostomia
- Dental prophylaxis within 4 weeks of screening -Tongue or lip piercing or presence of dental implants
- Professional desensitising treatment within 12 weeks of screening
- Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening.
- Teeth bleaching within 12 weeks of screening
- Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening
- Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine
- Sensitive tooth not expected to respond to treatment with an over-the counter dentifrice in the opinion of the investigator.
- Use of a desensitising dentifrice within six weeks of screening (participant will be required to bring their current dentifrice to the site in order to verify the lack of known anti-sensitivity ingredients)
- Daily doses of a medication which, in the opinion of the investigator, could interfere with the perception of pain -Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline.
- Daily doses of a medication which, in the opinion of the investigator, causes xerostomia
- Individuals who require antibiotic prophylaxis for dental procedures
- Any participant who, in the judgment of the investigator, should not participate in the study.
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
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
2012-12-06
Actual study completion date
2012-12-06
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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