Phase 3 N=140 Randomized Triple-blind Treatment

Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH

Dentin Hypersensitivity

Bottom Line

View on ClinicalTrials.gov: NCT04249336 ↗

Enrolled (actual)

140

Serious AEs

0.0%

Results posted

May 2021

Primary outcome: 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 percentage of change in mean scores — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Fluoro-Calcium-Phospho-Silicate based dentifrices (Drug); 8% Arginine based dentifrices (Drug); 8% Strontium Acetate (Drug); Sodium Fluoride (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Dow University of Health Sciences
Primary completion: Jan 2021

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

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04249336). 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.