Phase 3
Completed N=119
Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity
Dentine Hypersensitivity
Source: ClinicalTrials.gov NCT01827670 ↗
Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcomePrimary: Mean Change From Baseline in Schiff Sensitivity Score — 2.26; 2.25; 2.09; 0.78 Score on a scale — p=<0.0001
Summary
Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice daily brushing of a toothpaste containing stannous fluoride in comparison to marketed (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Schiff Sensitivity Score |
2.26; 2.25; 2.10; 1.27 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Schiff Sensitivity Score |
2.26; 2.25; 2.10; 1.27 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Tactile Sensitivity |
10.1; 10.4; 15.8; 24.6 | 0.0138 sig |
| SECONDARY Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS) |
58.40; 58.26; 50.32; 38.09 | 0.0003 sig |
| SECONDARY Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS) |
58.40; 58.26; 43.94; 22.17 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Participants with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.
- Participants with minimum of 20 natural teeth.
- At screening, a minimum of two accessible teeth (incisors, canines, premolars) that meet all of the following criteria.
- Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
- Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1.
- Teeth that are determined to be sensitive by the subject following a 1 second air blast to the cervical margin.
Exclusion Criteria
- Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
- Any condition which, in the opinion of the investigator, causes dry mouth.
- Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.
- Participant using of a desensitising dentifrice within 6 weeks of screening
Data sourced from ClinicalTrials.gov (NCT01827670). 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.