Efficacy of Fluoride Varnish Containing Xylitol Coated Calcium Phosphate Versus Conventional Fluoride Varnish in Management of Hypersensitivity of Exposed Root Surfaces in Adult Patients

Study Overview
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Brief Summary
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This clinical trial will be conducted to compare the efficacy of fluoride varnish containing xylitol coated calcium and phosphate or potassium nitrate gel versus conventional fluoride varnish in the management of hypersensitivity of non-carious exposed root surfaces in adult patients over a 12 months period.

Official Title
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Efficacy of Fluoride Varnish Containing Xylitol Coated Calcium Phosphate Versus Conventional Fluoride Varnish in Management of Hypersensitivity of Exposed Root Surfaces in Adult Patients: A Randomized Clinical Trial

Conditions
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Hypersensitivity

Intervention / Treatment
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* Drug: Fluoride varnish with xylitol coated calcium and phosphate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria of participants: Males or females. Age: 20-50 years old. Patients having at least one tooth with exposed root surface Teeth with hypersensitivity, VAS ≥5 Patients with good oral hygiene. Co-operative patients who show interest to participate in the study Exclusion criteria of participants: Patients with bad oral hygiene Patients with orthodontic appliances, or bridge work that might interfere with evaluation Patients who are allergic to any ingredients will be used in the study. Carious teeth Mobile teeth. (Grade 2 or Grade 3) Teeth with hypersensitivity, VAS <5 Patients with physical disabilities Pregnant or lactating women Other dental defects that causes pain. Allergy from any used materials or any allergic reaction during our clinical trial (The trial will be stopped at once and all the needed management against any allergic reaction will be done.)

Ages Eligible for Study
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Minimum Age: 20 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
Interventional Model Description: Dentin Hypersensitivity
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoride varnish with xylitol coated calcium and phosphate<br> | Drug: Fluoride varnish with xylitol coated calcium and phosphate<br>* Fluoride varnish with xylitol coated calcium and phosphate<br>|
| Active Comparator: Conventional Fluoride varnish<br> | Drug: Fluoride varnish with xylitol coated calcium and phosphate<br>* Fluoride varnish with xylitol coated calcium and phosphate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain due to Dentin Hypersensitivity | Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale | Two minutes before intervention | 
| Pain due to Dentin Hypersensitivity | Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale | 4 hours | 
| Pain due to Dentin Hypersensitivity | Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale | 2 days | 
| Pain due to Dentin Hypersensitivity | Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale | 4 months | 
| Pain due to Dentin Hypersensitivity | Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale | 8 months | 
| Pain due to Dentin Hypersensitivity | Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring Salivary pH | measuring Unstimulated Salivary pH using pH meter from 0-14 | Two minutes before intervention | 
| Measuring Salivary pH | measuring Unstimulated Salivary pH using pH meter from 0-14 | 4 hours | 
| Measuring Salivary pH | measuring Unstimulated Salivary pH using pH meter from 0-14 | 2 days | 
| Measuring Salivary pH | measuring Unstimulated Salivary pH using pH meter from 0-14 | 4 months | 
| Measuring Salivary pH | measuring Unstimulated Salivary pH using pH meter from 0-14 | 8 months | 
| Measuring Salivary pH | measuring Unstimulated Salivary pH using pH meter from 0-14 | 12 months | 
| Image analysis to assess amount of plaque adherence | Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface | 2 minutes before intervention | 
| Image analysis to assess amount of plaque adherence | Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface | 4 hours | 
| Image analysis to assess amount of plaque adherence | Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface | 2 days | 
| Image analysis to assess amount of plaque adherence | Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface | 4 months | 
| Image analysis to assess amount of plaque adherence | Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface | 8 months | 
| Image analysis to assess amount of plaque adherence | Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface | 12 months |