Clinical Evaluation of Efficacy of Shield Force Plus Varnish VS Sodium Fluoride on Dentin Hypersensitivity

Study Overview
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Brief Summary
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The aim of the study to compare the clinical effectiveness of Shield Force Plus (SFP) versus sodium fluoride varnish in the management of hypersensitivity of cervical dentin in adult patients for 8weeks.

Official Title
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Clinical Evaluation of Efficacy of Shield Force Plus Varnish Versus Sodium Fluoride on Cervical Dentin Hypersensitivity on Adult Patients: A Randomized Clinical Trial

Conditions
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Dentin Hypersensitivity, Dentin Desensitizing Agents

Intervention / Treatment
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* Drug: TOKUYAMA SHIELD FORCE PLUS
* Drug: Sodium Fluoride 5% Dental Varnish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with good oral hygiene. The age range of 18-65 years. Patients from both gender. Patients suffering from pain due to dentin hypersensitivity. Patients with sound first upper molars. Exclusion Criteria: Patients with teeth exhibiting mobility (grade 2 or 3). Patients with constant use of analgesic, carious lesions, fractured teeth, defective restorations or prosthesis. Patients with orthodontics appliance. Patients with allergy sufferers with any of the materials will be used in the study as shield force plus and sodium fluoride. Patients with carious, crowned upper first molars.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Shield Force Plus Varnish<br>Shield force plus (SFP), Self-reinforcing (SR) monomer technology supplied in the form of one component self-etching light-cured dental adhesive, which is characterized by an SR monomer component that penetrates the tooth substrate. Multi-point interactions with apatite calcium and three-dimensional cross-linking occur reactions.it forms a thin even, hard coating on the tooth surface that gives the tooth substrate a superior binding power. | Drug: TOKUYAMA SHIELD FORCE PLUS<br>* Self-reinforcing (SR) monomer technology<br>|
| 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>|

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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dentin hypersensitivity, Dentin sensitivity, Shield force plus, Dentin Desensitizing Agents, sodium fluoride varnish