Last updated: 09/11/2019 11:10:10
The Efficacy of an Occluding Dentifrice in Providing 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 an Occluding Dentifrice in Providing Relief from Dentinal Hypersensitivity
Trial description: This single centre, dual site, comparative design study will be used to investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term use
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Change from baseline in Schiff sensitivity score on Day 3
Timeframe: Baseline to 3 days
Secondary outcomes:
Change from baseline in Schiff sensitivity score post first treatment by direct application
Timeframe: Baseline to 60 seconds post first treatment
Change from baseline in tactile threshold post first treatment by direct application and on Day 3
Timeframe: Baseline, 60 seconds post first treatment, Day 3
Interventions:
Device: Stannous Fluoride dentifice
Other: Sodium Monofluorophosphate dentifrice
Enrollment:
488
Observational study model:
Not applicable
Primary completion date:
2016-03-06
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dentin Sensitivity
Product
SKF46655, SKF46656, sodium fluoride
Collaborators
Not applicable
Study date(s)
November 2015 to June 2016
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Good general and mental health with, in the opinion of the investigator or medically qualified designee:
- Pregnant or breast feeding women
- Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain.
Inclusion and exclusion criteria
Inclusion criteria:
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Good general and mental health with, in the opinion of the investigator or medically qualified designee: A. No clinically significant and relevant abnormalities in medical history or upon oral examination. B. Absence of any condition that would impact on the participant’s safety or wellbeing or affect the individual’s ability to understand and follow study procedures and requirements.
- Dental health At Screening: A. Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years. B. Good general oral health, with a minimum of 20 natural teeth. C. Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria:
- Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).
- Tooth with modified gingival index (MGI) score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1.
- Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response). At Baseline: D. Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria:
- Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff Sensitivity Score ≥ 2)
Exclusion criteria:
- Pregnant or breast feeding women
- Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain.
- Currently taking antibiotics or has taken antibiotics within two weeks of Baseline.
- Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia.
- 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.
- 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 (including cosmetic studies) 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
- Dental prophylaxis within four weeks of Screening.
- Tongue or lip piercing or presence of dental implants.
- Desensitizing treatment within eight weeks of Screening (professional sensitivity treatments and non-toothpaste sensitivity treatments).
- 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 eight weeks of Screening
- Tooth with evidence of current or recent caries, or reported treatment of decay within 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 toothpaste in the opinion of the investigator.
- Use of an oral care product indicated for the relief of dentine hypersensitivity within eight weeks of screening
- Individuals who require antibiotic prophylaxis for dental procedures
Trial location(s)
Location
GSK Investigational Site
Ellesmere Port, Cheshire, United Kingdom, CH65 4BW
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
Clinical study report
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
2016-03-06
Actual study completion date
2016-03-06
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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