Clinical trial NCT02924350: The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity (DH)
Official title: A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-10-05
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This was a single centre, 3 day, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study in participants with at least two sensitive teeth that met the study criteria at the Screening and Baseline visits. Study participants were in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at screening. Participants were assessed at Baseline (pre-treatment), immediately after first treatment, and after 3 days twice daily treatment, to monitor clinical efficacy and safety. At the Screening visit, participants gave their written informed consent to participate in the study. Demography, medical history and concomitant medications were recorded, followed by an oral examination which included an oral soft tissue (OST) examination and assessments to determine eligible teeth. Eligible participants were supplied with a regular fluoride dentifrice (containing 1450 parts per million (ppm) fluoride as sodium monofluorophosphate) to use twice daily (morning and evening) during the acclimatisation period (4-8 weeks) between Screening and Baseline. Each brushing occasion was recorded in a product use diary. First use of the acclimatisation dentifrice was carried out under supervision at the study site. At Baseline (Day 0, pre-treatment), eligibility to continue was assessed. Following an OST examination, tooth sensitivity was assessed (first to a tactile stimulus \[Yeaple probe, maximum 20 grams (g) pressure\], and then to an evaporative air stimulus \[Schiff sensitivity scale\]), and the inclusion/exclusion criteria were reviewed. Eligible participants were stratified and randomised to treatment. First use of allocated study treatment was by direct application to the 2 selected test teeth, and was carried out under supervision at the study site. The sensitivity of the 2 test teeth was reassessed immediately post-treatment, first to a tactile stimulus (Yeaple probe, maximum 80g pressure), and then to an evaporative air stimulus (Schiff sensitivity scale). Participants completed a supervised whole mouth brushing with their allocated study treatment prior to leaving the study site. Sensitivity was re-assessed after 3 days twice daily treatment. Each use of study treatment was recorded in a product use diary. Adverse events (AEs) were documented from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product. Incidents were documented from completion of the first use of investigational product until 5 days following last administration of study product.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in Schiff Sensitivity Score on Day 3
timeFrame: Baseline, Day 3
Secondary outcomes:
measure: 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
measure: 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
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: