N/A
Completed N=243
A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population
Dentin Sensitivity
Source: ClinicalTrials.gov NCT05750745 ↗
Enrolled (actual)
243
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice Versus [vs.] Negative Control) — -0.90; -0.74 score on a scale — p=0.0871
Summary
The purpose of this study is to evaluate the efficacy of the 0.454 percentage (%) weight/weight (w/w) stannous fluoride (SnF2) toothpastes for the relief of dentine hypersensitivity (DH) in China.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice Versus [vs.] Negative Control) |
-0.90; -0.74 | 0.0871 |
| SECONDARY Adjusted Mean Change From Baseline in Tactile Threshold (Gram [g]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control) |
25.86; 19.65 | 0.0972 |
| SECONDARY Adjusted Mean Change From Baseline in Visual Analog Scale (VAS) Score (Millimeters [mm]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control) |
-38.84; -33.02 | 0.0671 |
| SECONDARY Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control) |
-0.51; -0.38 | 0.0673 |
| SECONDARY Adjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control) |
11.74; 9.36 | 0.4050 |
| SECONDARY Adjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control) |
-21.92; -16.28 | 0.0346 sig |
| SECONDARY Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control) |
-0.36; -0.38; -0.67; -0.74 | 0.8256 |
| SECONDARY Adjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control) |
6.77; 9.36; 18.53; 19.65 | 0.5575 |
| SECONDARY Adjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control) |
-15.53; -16.28; -29.30; -33.02 | 0.8180 |
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 study procedures are performed.
- Participant who is willing and able to understand and comply with scheduled visits, product usage requirements and other study procedures.
- A participant in good general, oral 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.
- Participant who owns a smartphone with the WeChat application installed.
- A participant who presents the following oral and dental inclusions will apply at Screening (Visit 1):
- Self-reported history of tooth sensitivity lasting more than six months but not more than 10 years and experience DH symptoms at least 'once a week' or more frequently (as mentioned in Screening questionnaire).
- 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, with clinically confirmed DH.
- Each eligible tooth must meet all of the following criteria:
- Exposed dentine due to facial/cervical erosion, abrasion or gingival recession (EAR).
- Modified Gingival Index (MGI) = 0 directly adjacent to the exposed dentine (i.e., the test area) only
- Clinical mobility = 0.
- DH as evidenced by qualifying levels of tactile and evaporative (air) sensitivity (tactile threshold less than or equal to [ =] 2).
- A participant who presents the following oral and dental inclusions will apply at Baseline (Visit 2):
- All teeth identified at Screening (Visit 1) as eligible for Baseline assessments will be reassessed for tactile sensitivity first; eligible teeth with Baseline tactile threshold = 2 at Screening and Baseline.
- VAS >= 40 mm at Baseline.
- The clinical examiner will select two 'test teeth' from those eligible teeth which meet the tactile threshold and Schiff sensitivity score criteria at both Screening and Baseline, and the VAS criterion at Baseline.
- Each test tooth must demonstrate a consistent DH response to the evaporative (air) stimulus at both Screening and Baseline:
- Screening Schiff sensitivity score = 2 and Baseline Schiff sensitivity score = 2 or Screening Schiff sensitivity score = 3 and Baseline Schiff sensitivity score = 3.
Exclusion Criteria
- Participant who is an employee of the study site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the study site otherwise supervised by the investigator; or a sponsor employee directly involved in the conduct of the study or a member of their immediate family.
- Participant who has participated in, or has participated in, other studies (including non-medicinal studies) involving investigational product(s) within 30 days of Screening (Visit 1).
- Participant who is participating in, has participated in, a study evaluating a tooth desensitizing treatment within 8 weeks of Screening (Visit 1).
- Participant who is using, or has used, an oral care product indicated for DH relief within 8 weeks of Screening (Visit 1). Participant will be required to bring their current oral care products to Visit 1 for staff to verify the absence of known anti-sensitivity ingredients and DH claims.
- Participant who has had a professional de-sensitizing treatment within 8 weeks of Screening (Visit 1).
- Participant who habitually rinses with water during toothbrushing (self-reported at Screening Visit 1).
- Participant who seen to rinse with water while brushing with the acclimatization toothpaste during revie
Data sourced from ClinicalTrials.gov (NCT05750745). 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.