Last updated: 03/12/2020 11:40:12
The efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity (DH)
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 center study will investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving DH compared with a standard fluoride dentifrice after short term use.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from baseline in Schiff sensitivity score on Day 3
Timeframe: Baseline, Day 3
Secondary outcomes:
Change from baseline (Day 0 pre-treatment) in Schiff sensitivity score on Day 0 (after 60 seconds of single direct application)
Timeframe: At Baseline (Day 0 pre-treatment) and after 60 seconds of single direct application on Day 0
Change from baseline (Day 0 pre-treatment) in tactile threshold on Day 0 (after 60 seconds of single direct application) and Day 3
Timeframe: At Baseline (Day 0 pre-treatment), after 60 seconds of single direct application on Day 0 and Day 3
Interventions:
Other: Stannous fluoride
Other: Sodium monofluorophosphate
Enrollment:
205
Observational study model:
Not applicable
Primary completion date:
2017-17-03
Time perspective:
Not applicable
Clinical publications:
Creeth J, Maclure R, Seong J, Gomez-Pereira P, Budhawant C, Sufi F, Holt J, Chapman N, West N. Three randomised studies of dentine hypersensitivity reduction after short-term SnF2 toothpaste use. J Clin Periodontol. 2019 Aug 5. doi: 10.1111/jcpe.13175. PMID:31381157
Medical condition
Dentin Sensitivity
Product
sodium monofluorophosphate, stannous fluoride
Collaborators
Not applicable
Study date(s)
November 2016 to March 2017
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Consent: 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
- Aged 18-65 years inclusive
- A woman who is known to be pregnant or who is intending to become pregnant over the duration of the study
- A woman who is breast-feeding
Inclusion and exclusion criteria
Inclusion criteria:
- Consent: 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
- Aged 18-65 years inclusive
- Understands and is willing, able and likely to comply with all study procedures and restrictions
- Good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No clinically significant and relevant abnormalities of medical history or oral examination. b) Absence of any condition that would impact on the participants safety or wellbeing or affect the individual’s ability to understand and follow study procedures and requirements
- At Visit 1 (Screening): a) Self-reported history of DH lasting more than six months but not more than 10 years. b) 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 [Lobene, 1986] and a clinical Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response) mobility of ≤1, -Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response)
- At Visit 2, Baseline (Pre-treatment):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)
- Teeth which meet the EAR, MGI and mobility inclusion criteria and none of the dentition exclusion criteria at Screening should be assessed by tactile stimulus at Visit 2. Those teeth which meet the required tactile threshold (Yeaple ≤ 20g) should then be assessed by evaporative air stimulus. When two teeth that meet the study criteria are identified, no further testing is necessary
Exclusion criteria:
- A woman who is known to be pregnant or who is intending to become pregnant over the duration of the study
- A woman who is breast-feeding
- 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
- Previous participation in this study
- Participation in study 205084
- 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 The site for this protocol is the Clinical trials Unit in the Bristol Dental School and Hospital. Employees of the Bristol Dental School and Hospital not associated with the Clinical Trials unit are eligible to participate
- 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 on the selected Test Teeth
- Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening
- Vital teeth bleaching within 8 weeks of Screening
- Desensitizing treatment within 8 weeks of Screening (professional sensitivity treatments and non-dentifrice sensitivity treatments)
- 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 dentifrice in the opinion of the investigator
- Use of an oral care product indicated for the relief of dentine hypersensitivity 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)
- Daily doses of medication/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
- Currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline
- Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia
- Any participants 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
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
2017-17-03
Actual study completion date
2017-17-03
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
Three randomised studies of dentine hypersensitivity reduction after short‐term SnF2 toothpaste use
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