Efficacy of Desensitizers in Reducing Post-operative Sensitivity Following Composite Restorations

Study Overview
=================
Brief Summary
-----------------
Composite is one of the common aesthetic restorations used in the dentistry. With the advancements in the biomaterials the application of the composites has broadened. However due to various factors the composites are associated with dental sensitivity. Hence in our study we evaluate and compare the effectiveness of three desensitizing agents in reducing the post-treatment sensitivity for class I composite restoration.

Detailed Description
-----------------
A double-blind, randomized, controlled clinical trial was conducted in which 80 subjects requiring class I cavity were randomly assigned to 4 groups of 20 patients each: Group C (Control group), Group GL (Gluma group), Group SF (Shield Force Plus group), and Group TC (Telio CS group). The class 1 cavity was prepared and after etching, the desensitizers were applied (except in the control group) and later composite restoration was done. The postoperative pain/sensitivity level was recorded according to the Visual Analogue Scale (VAS) on intake of cold drinks; intake of hot drinks; and intake of sugar for different periods of time.

Official Title
-----------------
Efficacy of Three Commercially Available Desensitizers in Reducing Post-operative Sensitivity Following Composite Restorations: A Randomized Controlled Clinical Trial

Conditions
-----------------
Sensitivity

Intervention / Treatment
-----------------
* Combination Product: Gluma desensitiser
* Combination Product: Sheildforce Plus desensitiser
* Combination Product: Telio CS desensitiser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The selection criteria: Age was 20-45 years. Vital teeth, (electric pulp test) Apical periodontal ligament space radiographically identified The remaining dentin thickness at least 1mm. Exclusion Criteria: Restored, periodontally weak nonvital teeth are excluded.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>where no desensitizer application was done, | |
| Experimental: Group GL<br>applied with Gluma dentin desensitizer | Combination Product: Gluma desensitiser<br>* Gluma desensitiser was used before restoration.<br>|
| Experimental: Group SF<br>applied with Shieldforce desensitizer | Combination Product: Sheildforce Plus desensitiser<br>* Sheildforce Plus desensitiser was used before restoration.<br>|
| Experimental: Group TC<br>applied with Telio CS desensitizer | Combination Product: Telio CS desensitiser<br>* Telio CS desensitiser was used before restoration.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of application of the desensitisers on post operative sensitivity on the day of composite restoration on application of different stimuli like (i) Intake of cold drinks; (ii) Intake of hot drinks; and (iii) Intake of sugar. | The patients were given a questionnaire and instructed to record any postoperative pain/sensitivity level according to the Visual Analogue Scale (VAS) for restored tooth on the day of restoration on taking cold drinks, hot drinks, and sugar. | Within 24 hours | 
| Effect of application of the desensitisers on post operative sensitivity one week after the composite restoration on application of different stimuli like (i) Intake of cold drinks; (ii) Intake of hot drinks; and (iii) Intake of sugar. | The patients were given a questionnaire and instructed to record any postoperative pain/sensitivity level according to the Visual Analogue Scale (VAS) for restored tooth one week after the restoration on taking cold drinks, hot drinks, and sugar. | After one week | 
| Effect of application of the desensitisers on post operative sensitivity one month after the composite restoration on application of different stimuli like (i) Intake of cold drinks; (ii) Intake of hot drinks; and (iii) Intake of sugar. | The patients were given a questionnaire and instructed to record any postoperative pain/sensitivity level according to the Visual Analogue Scale (VAS) for restored tooth one month after the restoration on taking cold drinks, hot drinks, and sugar. | after one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sheildforce Plus, Gluma, Telio CS, Desensitisers