Comparison of Efficacy of 5% Fluorocalcium Phosphosilicate Dentifrice and Potassium Nitrate Dentifrice on Dentinal Hypersensitivity

Study Overview
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Brief Summary
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Aim of this study was to assess and compare the efficacy of a dentifrice containing 5% fluoro calcium phosphosilicate and dentifrice containing potassium nitrate on Dentinal Hypersensitivity (DH) compared to a placebo over a period of 6 weeks.

Detailed Description
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A total of 120 subjects were divided into 3 groups randomly. Group 1 was given the dentifrice containing 5% fluoro calcium phosphosilicate ,Group 2 was given the dentifrice containing potassium nitrate and group 3 was given placebo. Sensitivity scores (VAS score) were recorded at baseline, 2 weeks, 6 weeks.

Official Title
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Comparison Of Efficacy Of Dentifrice Containing 5% Fluorocalcium Phosphosilicate With Dentifrice Containing Potassium Nitrate And Placebo On Dentinal Hypersensitivity: A Triple Masked Randomized Controlled Clinical Trial

Conditions
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Dentinal Hypersensitivity

Intervention / Treatment
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* Other: 5% fluorocalcium phosphosilicate dentifrice
* Other: 5% potassium nitrate dentifrice
* Other: Placebo dentrifice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The volunteers selected at baseline were in good general health and should have at least 20 natural permanent teeth and history of hypersensitivity to hot, cold, sour stimuli on at least two teeth with a VAS score of ≥4. Exclusion Criteria: Patients with active cervical caries or deep abrasion requiring cervical filling, chipped teeth or fractured cusps, tender tooth in same quadrant as the hypersensitive teeth, Subjects using any type of desensitizing paste or desensitizing therapy for last 6 months, Pregnant/ lactating women or subjects with history of chronic use of anti-inflammatory and analgesic medications were excluded.

Ages Eligible for Study
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Minimum Age: 25 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>dentifrice containing 5% fluorocalcium phospho silicate prescribed and VAS score assessed at Baseline, 2 weeks, 6 weeks. | Other: 5% fluorocalcium phosphosilicate dentifrice<br>* dentifrice containing 5% fluorocalcium phosphosilicate and VAS score assessed at Baseline, 2 weeks, 6 weeks<br>|
| Sham Comparator: Group 2<br>dentifrice containing 5% potassium nitrate prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks . | Other: 5% potassium nitrate dentifrice<br>* 5% potassium nitrate dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks.<br>|
| Placebo Comparator: Group 3<br>dentifrice without the active ingredient prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks . | Other: Placebo dentrifice<br>* placebo dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale score for Dentinal Hypersensitivity | Based on a 10-cm VAS score which was used to measure tooth sensitivity, a pain-free response was allotted a score of zero whereas a score of 10 was given to subjects with excruciating pain or discomfort. | Change in VAS score from Baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dentinal Hypersensitivity, Visual Analogue Score