A Proof of Concept Study to Evaluate the Efficacy of Two Experimental Mouthwash Formulations in the Relief of Dentinal Hypersensitivity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- HALEON
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Schiff Sensitivity Score at Weeks 4, 6 and 8
Study Overview
Brief Summary
The aim of this study is to evaluate the clinical efficacy of two experimental mouthwash formulations, against a placebo mouthwash (without experimental ingredients). One experimental formulation to be used either once daily or twice daily, and the second experimental formulation and placebo, to be used twice daily for the treatment of dentinal hypersensitivity.
Detailed Description
This study will be an 8 week, randomized, examiner blind four treatment arm, parallel group design, stratified (by Baseline Schiff Sensitivity Score), in participants that meet all the criteria at the Screening and Baseline visits. Approximately 280 participants will be screened to randomize approximately 115 participants (to achieve approximately 30 participants to complete in each treatment group for twice daily usage and 15 to complete for the once daily usage group).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant who demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- •Participant understands and is willing, able and likely to comply with all study procedures and restrictions.
- •A participant with a minimum of 20 natural teeth and in good general health who suffer from tooth sensitivity.
- •At screening, participants with a minimum of four accessible nonadjacent teeth (incisors, canines, or pre-molars) with signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
- •At screening, self-reported history of Dentinal Hypersensitivity lasting more than 6 months but not more than 10 years.
- •At Baseline: Minimum of two, non-adjacent accessible teeth (incisors, canines, premolars), that meet all of the following criteria: - Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple less than or equal to [<=] 20 gram) and evaporative (air) assessment (Schiff Sensitivity Score greater than or equal to [>=] 2)
Exclusion Criteria
- •Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- •Women who are breastfeeding.
- •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.
- •Participation in a desensitising treatment study within 8 weeks of the Screening visit.
- •Previous participation in this study.
- •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.
- •Dental prophylaxis within 4 weeks of Screening.
- •Tongue or lip piercing or presence of dental implants.
- •Desensitizing treatment within 8 weeks of Screening.
- •Teeth bleaching within 8 weeks of Screening.
- •Any participant who, in the judgment of the investigator, should not participate in the study.
Outcomes
Primary Outcomes
Change From Baseline in Schiff Sensitivity Score at Weeks 4, 6 and 8
Time Frame: Baseline, Weeks 4, 6 and 8
Evaporative (air) sensitivity will be assessed by the participant's response to an evaporative (air) stimulus administered by the clinical examiner. Participant response will be evaluated immediately following application of the stimulus using the Schiff sensitivity scale (0= Participant does not respond to air stimulation, 1= Participant responds to air stimulus but does not request discontinuation of stimulus, 2= Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of stimulus). A decrease in Schiff sensitivity score indicates improvement. Change from Baseline will be calculated by subtracting Baseline score from the score at the indicated timepoints.
Change From Baseline in Tactile Threshold at Weeks 4, 6 and 8
Time Frame: Baseline, Weeks 4, 6 and 8
Tactile sensitivity will be assessed by the participant's response to a tactile stimulus administered by the clinical examiner using a constant pressure probe (Yeaple probe). After each application of the stimulus, the participant will be asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses will be recorded as the tactile threshold in gram. An increase in tactile threshold (gram) indicates improvement. Change from Baseline will be calculated by subtracting Baseline value from the value at the indicated timepoints.
Secondary Outcomes
- Change From Baseline in Individual Questions Score from Dentine Hypersensitivity Experience Questionnaire (DHEQ) at Weeks 4 and 8(Baseline, Weeks 4 and 8)
- Change From Baseline in DHEQ Total Score at Week 4 and 8(Baseline, Weeks 4 and 8)
- Change From Baseline in Global Oral Health Score at Week 4 and 8(Baseline, Weeks 4 and 8)
- Change From Baseline in Effect on Life Overall Score at Week 4 and 8(Baseline, Weeks 4 and 8)