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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-27

Study Completion Date

2021-01-16

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Dentin Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Statistician will be masked.

Study Groups

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BioMin F Dentifrices

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

Group Type EXPERIMENTAL

Fluoro-Calcium-Phospho-Silicate based dentifrices

Intervention Type DRUG

Bio-Active glass based formulation

Colgate Sensitive Pro relief Trade Mark Dentifrices

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

Group Type ACTIVE_COMPARATOR

8% Arginine based dentifrices

Intervention Type DRUG

Tubular occluding formulation

Sensodyne Rapid Action Trade Mark Dentifrices

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

Group Type ACTIVE_COMPARATOR

8% Strontium Acetate

Intervention Type DRUG

Tubular occluding formulation

Colgate Total Trade Mark

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

Group Type PLACEBO_COMPARATOR

Sodium Fluoride

Intervention Type DRUG

No claim of relieving Dentin Hypersensitivity

Interventions

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Fluoro-Calcium-Phospho-Silicate based dentifrices

Bio-Active glass based formulation

Intervention Type DRUG

8% Arginine based dentifrices

Tubular occluding formulation

Intervention Type DRUG

8% Strontium Acetate

Tubular occluding formulation

Intervention Type DRUG

Sodium Fluoride

No claim of relieving Dentin Hypersensitivity

Intervention Type DRUG

Other Intervention Names

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BioMin F Colgate Sensitive Pro-Relief TM Sensodyne Rapid ActionTM Colgate Total TM

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes