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

Study Overview
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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

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.

Official Title
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Immediate And Sustained Treatment Response Of Commercially Available BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In Dentin Hypersensitivity - A Randomized Clinical Trial

Conditions
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Dentin Hypersensitivity

Intervention / Treatment
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* Drug: Fluoro-Calcium-Phospho-Silicate based dentifrices
* Drug: 8% Arginine based dentifrices
* Drug: 8% Strontium Acetate
* Drug: Sodium Fluoride


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BioMin F Dentifrices<br>Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily. | Drug: Fluoro-Calcium-Phospho-Silicate based dentifrices<br>* Bio-Active glass based formulation<br>* Other names: BioMin F;|
| Active Comparator: Colgate Sensitive Pro relief Trade Mark Dentifrices<br>Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily. | Drug: 8% Arginine based dentifrices<br>* Tubular occluding formulation<br>* Other names: Colgate Sensitive Pro-Relief TM;|
| Active Comparator: Sensodyne Rapid Action Trade Mark Dentifrices<br>Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily. | Drug: 8% Strontium Acetate<br>* Tubular occluding formulation<br>* Other names: Sensodyne Rapid ActionTM;|
| Placebo Comparator: Colgate Total Trade Mark<br>Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily. | Drug: Sodium Fluoride<br>* No claim of relieving Dentin Hypersensitivity<br>* Other names: Colgate Total TM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | SCHIFF cold air sensitivity scale was used to measure the intensity of pain due to dentin hypersensitivity using air blast stimulus. Patients' response of pain was assessed by the doctor according to following score range from; 0(no response of pain), 1 (pain response but no request of discontinuity of stimulus), 2(pain response with request of discontinuity of stimulus), 3(Immediate pain response for discontinuity of stimulus). Percent change in mean scores = ( one minute score-Baseline score) / Baseline score | (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | Visual Analogue Scale was used to measure the intensity of pain due to dentin hypersensitivity using mechanical stimulus. Patient's response of pain was assessed on vertical line of 0 to 10cm by asking him to move finger on the line and stop it where he felt pain. Score range from; 0 (no pain at 0cm), 1(mild pain at 1cm), 2(mild pain at 2cm), 3(mild pain at 3cm), 4(moderate pain at 4cm), 5(moderate pain at 5cm), 6(moderate pain at 6cm), 7(severe pain at 7cm), 8(severe pain at 8cm), 9(severe pain at 9cm),10(worst imaginable pain at 10cm). Percent change in mean scores = (one minute score-Baseline score) / Baseline score | (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4) | 
| Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | Visual Analogue Scale was used to measure the intensity of pain due to dentin hypersensitivity using Water Jet Stimulus. Patient's response of pain was assessed on vertical line of 0 to 10cm by asking him to move finger on the line and stop it where he felt pain. Score range from; 0 (no pain at 0cm), 1(mild pain at 1cm), 2(mild pain at 2cm), 3(mild pain at 3cm), 4(moderate pain at 4cm), 5(moderate pain at 5cm), 6(moderate pain at 6cm), 7(severe pain at 7cm), 8(severe pain at 8cm), 9(severe pain at 9cm),10(worst imaginable pain at 10cm). Percent change in mean scores = (one minute score-Baseline score) / Baseline score | (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dentine hypersensitivity, Dentine Sensitivity, Oral dentifrices, Bio-active glasses