Evaluation of Desensitization Protocols in Reduction of Dentin Hypersensitivity

Study Overview
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Brief Summary
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The aim of this study is through a double blind randomized clinical trial, evaluate the effectiveness of different clinical protocols in the reduction of dentin hypersensitivity. The desensitization approach (single agent or associated agents) and the long-term effectiveness (baseline, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks) will be evaluated. Data will be collected, tabulated and submitted to statistical analysis.

Detailed Description
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Dentin hypersensitivity is characterized as an acute and short-term pain with multifactorial etiology. This condition is a clinical challenge due to the different treatment protocols available. Therefore, the aim of this study is through a double blind randomized clinical trial, evaluate the effectiveness of different clinical protocols in the reduction of dentin hypersensitivity. Thirty-two patients with dentin hypersensitivity in at least three teeth will be selected.The teeth will be randomly divided into two different groups according to the desensitization approach (single agent with neural action; single agent with obliterating action; associated technique (neural and obliterator agents). The dentin hypersensitivity level will be evaluated immediately after desensitization and after 1, 2, 4,12 and 24 weeks. Data will be collected, tabulated and submitted to statistical analysis.

Official Title
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Evaluation of Desensitization Protocols in Reduction of Dentin Hypersensitivity: A Randomized Clinical Trial

Conditions
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Hypersensitivity Dentin, Dentin Sensitivity, Dentin Hypersensitivity, Dentine Hypersensitivity

Intervention / Treatment
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* Drug: UltraEZ
* Drug: Enamelast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy individuals Both genres, interested in the treatment of Dentin Hypersensitivity Patients with all teeth in their mouth Patients who have at least three teeth with Dentin hypersensitivity in different quadrants Good oral hygiene Exclusion Criteria: Caries or unsatisfactory restorations Presence of periodontal disease and or parafunctional habits Cracks or enamel fractures Extensive or unsatisfactory restorations Recent restorations involving the labial surface Pulpitis Dentures Orthodontics Smokers Pregnant women Gastroesophageal disease presence Uncontrolled systemic disease Severe bruxism Constant use of analgesic Allergic response to dental products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Active Comparator: Neural agent<br>UltraEZ. Prophylaxis of the teeth; an application every 48 hours; 4 sessions | Drug: UltraEZ<br>* Prophylaxis, apply uniformly on the teeth, wait 15 minutes, remove the gel from the teeth with cotton and abundant water.<br>|
| Active Comparator: Obliterator agent<br>Enamelast. Prophylaxis of the teeth; an application every 48 hours; 4 sessions | Drug: Enamelast<br>* Prophylaxis; dry the teeth; apply uniformly on the teeth with a thin layer.<br>|
| Active Comparator: Associative approach<br>UltraEZ and Enamelast. Prophylaxis of the teeth; an application every 48 hours; 4 sessions. In each session, fistly the UltraEZ (neural agent) will be applied and after the Enamelast (obliterator agent.) | Drug: UltraEZ<br>* Prophylaxis, apply uniformly on the teeth, wait 15 minutes, remove the gel from the teeth with cotton and abundant water.<br>Drug: Enamelast<br>* Prophylaxis; dry the teeth; apply uniformly on the teeth with a thin layer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of cervical dentin hypersensitivity by using visual analog scale | Evaluation of the reduction in dentin hypersensitivity levels by using visual analog scale with a 24 weeks follow up. | 24 weeks |