N/A
Completed N=197
A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity in a Chinese Population
Dentin Sensitivity
Source: ClinicalTrials.gov NCT04950465 ↗
Enrolled (actual)
197
Serious AEs
0.5%
Results posted
Oct 2023
Primary outcomePrimary: Change From Baseline in Schiff Sensitivity Score at Week 8 (Test Dentifrice Versus [vs.] Negative Control) — -0.98; -1.14 Score on a scale — p=0.2639
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Schiff Sensitivity Score at Week 8 (Test Dentifrice Versus [vs.] Negative Control) |
-0.98; -1.14 | 0.2639 |
| SECONDARY Change From Baseline in Tactile Threshold at Week 4 and 8 (Test Dentifrice vs. Negative Control) |
9.22; 7.42; 16.63; 11.82 | 0.6978 |
| SECONDARY Change From Baseline in Schiff Sensitivity Score at Week 4 (Test Dentifrice vs. Negative Control) |
-0.79; -0.75 | 0.7645 |
| SECONDARY Change From Baseline in Schiff Sensitivity Score at Week 4 and 8 (Positive Control vs. Negative Control) |
-0.76; -0.75; -0.99; -1.14 | 0.9728 |
| SECONDARY Change From Baseline in Tactile Threshold at Week 4 and 8 (Positive Control vs. Negative Control) |
4.59; 7.42; 11.05; 11.82 | 0.1682 |
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 ( =) 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 =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
Data sourced from ClinicalTrials.gov (NCT04950465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.