Evaluation of Dentin Hypersensitivity Using Glass Ionomer Cements

Study Overview
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Brief Summary
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The aim of this randomized, double-blind, split-mouth clinical trial is to evaluate and compare the desensitizing efficacies of the resin-modified glass ionomer cement ClinproTM XT (3M ESPE, Minnesota, USA) and the conventional glass ionomer cement Vidrion R (SS White, Gloucester, UK) at 2-year follow-up.

Detailed Description
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Subjects will require to have at least two teeth in different hemiarchs with dentin hypersensitivity. Teeth will be randomized into 2 groups, receiving either Clinpro XT or the conventional glass ionomer cement Vidrion R. Prior to the desensitizing treatment (baseline), painful symptoms will be assessed by tactile and air blast tests using the Visual Analogue Scale (VAS). Treatment evaluations will be conducted up to 2-year post-treatment.

Official Title
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Evaluation of the Effectiveness of Dentin Hypersensitivity Treatment Using Glass Ionomer Cements: A Randomized Clinical Trial

Conditions
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Dentin Hypersensitivity

Intervention / Treatment
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* Drug: Resin-modified glass ionomer cement Clinpro XT
* Drug: Glass Ionomer cement Vidrion R


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects between 18 and 70 years old At least 2 teeth with dentin hypersensitivity in two different hemiarchs Dental elements with hypersensitivity without any pulp alteration People who are not taking any medication and women who are not pregnant Patients without eating disorders or very acidic diets. Exclusion Criteria: Teeth with hypersensitivity that presented extensive or unsatisfactory restorations, fractures, periodontal alterations, caries lesions, orthodontic brackets, endodontic treatments, pulp alterations. Subjects who received any desensitizing therapy during the last 3 months Subjects being under analgesics/anti-inflammatory drugs at the time of the study Teeth with hypersensitivity and non-carious cervical lesions

Ages Eligible for Study
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Minimum Age: 28 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinpro XT (3M ESPE, Minnesota, USA)<br>Resin-modified glass ionomer cement | Drug: Resin-modified glass ionomer cement Clinpro XT<br>* Clinpro XT (3M ESPE, Minnesota, USA)<br>* Other names: Clinpro XT (3M Espe, USA);|
| Active Comparator: Vidrion R (SS White, Gloucester, UK)<br>Conventional glass ionomer cement | Drug: Glass Ionomer cement Vidrion R<br>* Vidrion R (SS White, Gloucester, UK)<br>* Other names: Vidrion R (SS White, Gloucester, UK);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores as measured by the Visual Analog Scale (VAS) | Tactile and air blast tests to evaluate pain with VAS | Change from Baseline in Pain Scores at 20 minutes; at 7, 15, 21, 30 days; and after 3, 6, 12, 24 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dentin Sensitivity, Dentin Desensitizing Agents, Glass Ionomer Cements, Randomized Controlled Trial