Phase 3
Completed N=140
Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH
Dentin Hypersensitivity
Source: ClinicalTrials.gov NCT04249336 ↗
Enrolled (actual)
140
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus — 18; 45; 37; 15 percentage of change in mean scores — p=<0.05
◆ Published Evidence
Established
34citations · ~7 / year
Comparative efficacy of BioMin-F, Colgate Sensitive Pro-relief and Sensodyne Rapid Action in relieving dentin hypersensitivity: a randomized controlled trial.
Summary
This will be multi-centered, triple blinded, randomized, four parallel treatments assigned study to compare clinical efficacy of commercially available dentifrices with placebo for immediate and sustained relief from Dentin Hypersensitivity after short term use.
Condition or disease: Dentin hypersensitivity Intervention/Treatment: Product 1; Fluoro-Calcium-Phospho-silicate based BioMin F Product 2; Pro-Argin formula based Colgate Sensitive Pro-Relief Product 3; Strontium Acetate based Sensodyne Rapid Action Product 4; Sodium Fluoride based Colgate Total
Linked Publications
-
Comparative efficacy of BioMin-F, Colgate Sensitive Pro-relief and Sensodyne Rapid Action in relieving dentin hypersensitivity: a randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus |
18; 45; 37; 15; 27; 56 | <0.05 sig |
| SECONDARY Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus |
25; 56; 46; 16; 27; 61 | <0.05 sig |
| SECONDARY Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus |
22; 52; 46; 18; 27; 56 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Subjects with at least two teeth sensitive to cold, touch and air blow stimulus
- Sensitive teeth anterior to molars either due to erosions or abrasions with or without associated gingival recession
- Teeth with Linear Visual Analogue Scale (VAS) score of ≥ 4 and code 2 of Schiff Cold Air Sensitivity Scale on screening.
Exclusion Criteria
- Subjects with worst pain response at 100mm on VAS.(Visual Analog Scale)
- Teeth with orthodontic or prosthetic appliances, Caries, restorations or cracks
- Localized or generalized gingivitis or pulpitis with heavy calculus
- Periodontal surgery in the preceding three months
- Patients using any desensitizing tooth paste or mouth wash up to six weeks before study and taking drugs like anti-inflammatory, sedatives, tranquilizers, analgesics in routine.
- Pregnant or breastfeeding females.
Data sourced from ClinicalTrials.gov (NCT04249336) and the linked publication. 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.