Last updated: 07/17/2024 17:36:09
A Clinical Study to Evaluate a Stannous Fluoride Toothpaste for the Relief of Dentinal Hypersensitivity
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, 8 Week Clinical Study to Evaluate the Efficacy of an Experimental Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity
Trial description: The purpose of this study is to provide evidence of clinical efficacy of an experimental dentifrice containing stannous fluoride (SnF2) compared to regular fluoride dentifrice in the reduction of dentinal hypersensitivity (DH). This study will be considered successful if there is a statistically significant difference in the primary efficacy variable, change from baseline in Schiff sensitivity score, after 8 weeks of treatment.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in Schiff sensitivity score after 8 weeks of treatment
Timeframe: Baseline, Week 8
Secondary outcomes:
Change from Baseline in tactile threshold after 8 weeks of treatment
Timeframe: Baseline, Week 8
Interventions:
Other: 0.454% Stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF): 1450 ppm fluoride in total
Other: 1400 ppm fluoride as sodium monofluorophosphate (SMFP)
Other: Stannous Chloride (SnCl2) and 0.15% NaF: 1450 ppm fluoride in total
Enrollment:
185
Observational study model:
Not applicable
Primary completion date:
2018-02-02
Time perspective:
Not applicable
Clinical publications:
Tao D, Ling MR, Feng XP, Gallob J, Souverain A, Yang W, Alavi A. Efficacy of an anhydrous stannous fluoride toothpaste for relief of dentine hypersensitivity: a randomised clinical study. PMID:32391584
Medical condition
Dentin Sensitivity
Product
GSK3730661, SKF46655, SKF46656, sodium fluoride
Collaborators
Not applicable
Study date(s)
November 2017 to February 2018
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 70 years
Accepts healthy volunteers
Yes
- Evidence of a personally signed and dated informed consent indicating the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- Male and female participants who, at the time of screening, are between the ages of 18 and 70 years, inclusive.
- Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are GSK employees directly involved in the conduct of the study.
- Participation in another clinical study (including cosmetic studies), or receipt of an investigational drug within 30 days prior to the Screening visit and/or during study participation.
Inclusion and exclusion criteria
Inclusion criteria:
- Evidence of a personally signed and dated informed consent indicating the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- Male and female participants who, at the time of screening, are between the ages of 18 and 70 years, inclusive.
- Participants who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- Good general and mental health, in the opinion of the investigator or medically qualified designee.
- Male participants able to father children and female participants of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 5 days after the last dose of assigned treatment. Female subjects who are not of childbearing potential must these meet requirements: Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state; have undergone a documented hysterectomy and/or bilateral oophorectomy; have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential.
- The following oral and dental inclusions will apply at Screening (Visit 1): Self-reported history of dentinal hypersensitivity lasting more than six months but not more than 10 years, good general oral health, with a minimum of 20 natural teeth, 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 a qualifying tactile stimulus (Yeaple ≤20g) qualifying evaporative air assessment (Schiff sensitivity score >=2). The following dental inclusions will apply at Baseline (Visit 2): Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), with signs of sensitivity, measured by response to a qualifying tactile stimulus (Yeaple ≤20g) and evaporative air assessment (Schiff sensitivity score ≥2). The two selected test teeth must have also qualified at Screening for this criteria. The Investigator will select two Test Teeth from those which meet both the tactile threshold and Schiff sensitivity score criteria, in addition to meeting all other criteria. Test teeth should not be adjacent to each other and preferably in different quadrants.
Exclusion criteria:
- Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are GSK employees directly involved in the conduct of the study.
- Participation in another clinical study (including cosmetic studies), or receipt of an investigational drug within 30 days prior to the Screening visit and/or during study participation.
- Participation in another tooth desensitizing treatment study within 8 weeks of the Screening visit.
- Acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Pregnant female participants. This will be confirmed verbally at Screening and confirmed by Urine pregnancy testing (carried out on all female participants of child bearing potential) at the Baseline visit.
- Breastfeeding female participants.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Recent history (within the last year) of alcohol or other substance abuse.
- Unwilling or unable to comply with the lifestyle guidelines described in this protocol.
- Participants who have previously been enrolled in this study.
- General oral and dental exclusions: Dental prophylaxis within 4 weeks of Screening, tongue or lip piercing or presence of dental implants, 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 8 weeks of Screening, use of an over-the-counter (OTC) desensitizing product (e.g. dentifrice) and/or professional desensitizing treatment within 8 weeks of Screening. participants will be required to bring their current oral care products to the site in order to verify the absence of known anti-sensitivity ingredients.
- Specific dental exclusions for test teeth: sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator, 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.
- Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening.
- Concomitant Medication: Daily doses of medication/treatments or traditional herbal ingredients/treatments which, in the opinion of the investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs. Examples of herbal ingredients/treatments include clove oil, olive oil, or other treatments that are directly applied to the oral cavity for the treatment of oral health conditions. Currently taking antibiotics or has taken antibiotics within 2 weeks of Screening and/or Baseline, Daily dose of a medication which, in the opinion of the investigator, is causing 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
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
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
2018-02-02
Actual study completion date
2018-02-02
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
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Additional information
Efficacy of an anhydrous stannous fluoride toothpaste for relief of dentine hypersensitivity: a randomised clinical study
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