An 8 Week, Randomised, Examiner-blind, Controlled Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity in a Chinese Population
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dentin Sensitivity
- Sponsor
- HALEON
- Enrollment
- 271
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Schiff Sensitivity Score at Week 8 (Test Dentifrice Versus [vs.] Negative Control)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to support long-term dentinal hypersensitivity (DH) relief claims of 0.454 percent (%) stannous fluoride (SnF2) containing toothpastes in China.
Detailed Description
This study will be a single centre, randomised, controlled, examiner-blind, 3 treatment arm, parallel group design study, stratified by maximum baseline Schiff sensitivity score (of the 2 selected 'test teeth'), with a treatment period of 8 weeks, to investigate the clinical efficacy of a SnF2 dentifrice in the reduction of DH in a Chinese population. The SnF2 test dentifrice will be compared to commercialised negative and positive control dentifrices. Participants will be instructed to brush teeth with their assigned dentifrice according to the product use instructions provided. DH assessments will be conducted at Baseline, 4 and 8 weeks. Participants will also be requested to complete a short-form version of the Dentine Hypersensitivity Experience Questionnaire (DHEQ-15) at the Baseline and Week 8 Visits.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- •A participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- •A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
- •A participant who presents 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:
- •i. Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).
- •ii. Tooth with MGI score ≤1 adjacent to the test area (exposed dentine) only and a clinical mobility of less than or equal to (\<=)
- •iii. Tooth with signs of sensitivity measured by a qualifying tactile stimulus (yeaple \[\<=\] 20 gram \[g\]) and qualifying evaporative air assessment (Schiff sensitivity score more than or equal to (\>=) 2).
Exclusion Criteria
- •A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH employee directly involved in the conduct of the study or a member of their immediate family.
- •A Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- •A participant who has participated in another tooth desensitising treatment study within 8 weeks of the Screening visit.
- •A participant with, in the opinion of the investigator or medically qualified designee, has an acute or chronic medical or psychiatric condition or laboratory abnormality 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 or medically qualified designee, would make the participant inappropriate for entry into this study.
- •A participant who is pregnant or intending to become pregnant over the duration of the study. This will be confirmed verbally at Screening.
- •A participant who is breastfeeding.
- •A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- •A participant who rinses with water during the first minute of toothbrushing at the Screening visit.
- •A participant unwilling or unable to comply with product usage instructions or Lifestyle Considerations that will be described in the protocol.
- •A participant with history of regular alcohol and/or substance abuse.
Outcomes
Primary Outcomes
Change From Baseline in Schiff Sensitivity Score at Week 8 (Test Dentifrice Versus [vs.] Negative Control)
Time Frame: Baseline and Week 8
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participants were scored using Schiff sensitivity scale range of 0-3; 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 the stimulus. Higher score indicates worst outcome (more sensitivity). Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value.
Secondary Outcomes
- Change From Baseline in Schiff Sensitivity Score at Week 4 and 8 (Positive Control vs. Negative Control)(Baseline, Week 4 and Week 8)
- Change From Baseline in Tactile Threshold at Week 4 and 8 (Test Dentifrice vs. Negative Control)(Baseline, Week 4 and 8)
- Change From Baseline in Tactile Threshold at Week 4 and 8 (Positive Control vs. Negative Control)(Baseline, Week 4 and Week 8)
- Change From Baseline in Schiff Sensitivity Score at Week 4 (Test Dentifrice vs. Negative Control)(Baseline and Week 4)