Clinical trial NCT04950465: A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity in a Chinese Population
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Lead sponsor: HALEON
Sponsor class: INDUSTRY
First posted: 2021-07-06
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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):

  1. Self-reported history of dentinal hypersensitivity lasting more than six months but not more than 10 years.
  2. Good general oral health, with a minimum of 20 natural teeth.
  3. 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 (\<=)1.

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).

The following dental inclusions will apply at Baseline (Visit 2):

d) 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 2 selected 'test teeth' must have also qualified at Screening for this criteria.

- Participant must own a smartphone with the WeChat application installed.

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.
* A participant who has received treatment with another investigational product within 30 days of the first dose of investigational product.
* A participant who has had dental prophylaxis within 4 weeks of Screening, or who requires antibiotic prophylaxis for dental procedures.
* A participant with a tongue or lip piercing.
* A participant with advanced periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening.
* A participant who has had teeth bleaching within 8 weeks of Screening.
* A participant who has used an over-the-counter (OTC) desensitising product (Eg. dentifrice) and/or professional desensitising 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.
* A participant with exposed tooth 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.
* A participant with sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine Eg. current or recent dental caries, or reported treatment of decay within 12 months of Screening.
* A participant who has taken 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, antidepressants, 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.
* A participant who is taking antibiotics and/or has taken antibiotics within 2 weeks of Screening and/or Baseline.
* A participant who has taken daily dose of a medication which, in the opinion of the investigator, is causing xerostomia.
* Any participant who, in the judgment of the investigator, should not participate in the study.

Primary outcomes:
measure: Change From Baseline in Schiff Sensitivity Score at Week 8 (Test Dentifrice Versus [vs.] Negative Control)
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change From Baseline in Tactile Threshold at Week 4 and 8 (Test Dentifrice vs. Negative Control)
timeFrame: Baseline, Week 4 and 8
measure: Change From Baseline in Schiff Sensitivity Score at Week 4 (Test Dentifrice vs. Negative Control)
timeFrame: Baseline and Week 4
measure: Change From Baseline in Schiff Sensitivity Score at Week 4 and 8 (Positive Control vs. Negative Control)
timeFrame: Baseline, Week 4 and Week 8
measure: Change From Baseline in Tactile Threshold at Week 4 and 8 (Positive Control vs. Negative Control)
timeFrame: Baseline, Week 4 and Week 8
Other outcomes:
Locations:
city: Shanghai
country: China
facility: GSK Investigational Site
Study officials:
affiliation: Preventive Dentistry Depart-ment, Shanghai Ninth Peo-ple's Hospital, Shanghai Jiao-tong University, School of Medicine
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: