Clinical Assessment of Bifluorid 10 vs Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient

Study Overview
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Brief Summary
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Aim of the study will be conducted to compare the efficacy of bifluoride (NaF and CaF) versus conventional fluoride varnish (Sodium Flouride) in the management of hypersensitivity of exposed cervical area in adult patients over 2 month

Official Title
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Quantitative Clinical Assessment of Bifluorid 10 Versus Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient: A Randomized Clinical Trial

Conditions
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Hypersensitivity, Dentin Sensitivity

Intervention / Treatment
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* Drug: Bifluorid 10 ,VOCO
* Drug: Sodium Fluoride 5% Dental Varnish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy patient with free medical history. Age range 18-60 years old. Good oral hygiene Patients suffering from pain due to dentin hypersensitivity. Patient with sound first molar . Exclusion Criteria: Patients using desensitizing agents, receiving periodontal treatment or had received nonsurgical periodontal treatment in the last three months. Patient wearing orthodontic appliance. Patient with teeth having a painful condition involving the pulp and periapical region. Patients who had allergy to materials will be used in the study. Pregnancy. Patient who does not consent to participation. Patient who does not attend to the follow up. A patient who has a carious first molar.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bifluorid 10 varnish<br>Bifluorid 10 (NaF and CaF) lead to reduce the dentin hypersensitivity, the sodium fluoride (NaF) dissociates and releases F ions, that diffuse through the tubules and then precipitates as calcium fluoride as a consequence of the high of calcium content in saliva and dentinal fluid ,The calcium fluoride (CaF) present in the varnish composition diffuses into the tubules and block the canal with a semi-permanent protective layer.The calcium fluoride is added to block the dentin tubules mechanically, by the combination with the calcium fluoride resulted from the sodium fluoride reaction to the calcium of dentin. | Drug: Bifluorid 10 ,VOCO<br>* NaF and CaF 10 %<br>* Other names: Bifluorid 10;|
| Active Comparator: sodium fluoride varnish<br>Topical application of varnish fluoride (sodium fluoride NaF) effect on exposed dentine as a desensitizing agent, the varnish fluoride process is caused by the reaction between NaF and calcium ions resulting in calcium fluoride crystals being deposited on the openings of the dentinal tubules that decrease pain. | Drug: Sodium Fluoride 5% Dental Varnish<br>* 5% NaF<br>* Other names: conventional sodium fluoride varnish;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dentin hypersensitivity | measurement of dentin hypersensitivity by VAS scale | pre-intervention | 
| Dentin hypersensitivity | measurement of dentin hypersensitivity by VAS scale | 2 min | 
| Dentin hypersensitivity | measurement of dentin hypersensitivity by VAS scale | 1 week | 
| Dentin hypersensitivity | measurement of dentin hypersensitivity by VAS scale | 4 weeks | 
| Dentin hypersensitivity | measurement of dentin hypersensitivity by VAS scale | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dentinal tubule occlusion | Percentage of dentinal tubule occlusion measure by scanning electron microscope SEM | Pre-intervention | 
| Dentinal tubule occlusion | Percentage of dentinal tubule occlusion measure by scanning electron microscope SEM | 8 weeks |