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

Dow University of Health Sciences

Status and phase: Completed; Phase 3

Conditions: Dentin Hypersensitivity

Treatments: Drug: Sodium Fluoride; Drug: 8% Strontium Acetate; Drug: 8% Arginine based dentifrices; Drug: Fluoro-Calcium-Phospho-Silicate based dentifrices

Study type: Interventional

Funder types: Other

Identifiers

NCT04249336

PRS4072

Details and patient eligibility

About

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

Full description

It is a randomized controlled clinical trial with non invasive topical intervention in 140 adult patients of 18 to 60 years age, that will be selected randomly after screening and diagnosis of dentin hypersensitivity, in dental Out Patient Department of Periodontology. Written informed consent will be obtained. Participants will be allocated randomly into four equal study arms for parallel treatment assignment with dentifrices named BioMin F, Colgate Sensitive Pro-Relief Trade Mark,Sensodyne rapid action Trade Mark and Colgate Total Trade Mark dentifrices. Colgate total Trade Mark dentifrices does not claim pain relief in Dentin Hypersensitivity. Interim efficacy will be assessed immediately after topical application on sensitive teeth, in one minute, after 5 minutes, on day three and week 4 respectively. Dentin hypersensitivity will be tested with mechanical stimulus, evaporative air blast stimulus and water jet stimulus. It will be measured on Visual Analogue Scale and Schiff cold air sensitivity scale (SCASS). Statistical analysis will be done using ANOVA in Statistical Package for Social Sciences software 21.

Enrollment: 140 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 4 patient groups, including a placebo group

BioMin F Dentifrices

Experimental group

Description:

Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.

Treatment:

Drug: Fluoro-Calcium-Phospho-Silicate based dentifrices

Colgate Sensitive Pro relief Trade Mark Dentifrices

Active Comparator group

Description:

Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.

Treatment:

Drug: 8% Arginine based dentifrices

Sensodyne Rapid Action Trade Mark Dentifrices

Active Comparator group

Description:

Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.

Treatment:

Drug: 8% Strontium Acetate

Colgate Total Trade Mark

Placebo Comparator group

Description:

Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.

Treatment:

Drug: Sodium Fluoride