Evaluation of Gluma Desensitizer in Post-treatment Sensitivity in Posterior Composite

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of Gluma desensitizer in controlling immediate post-treatment sensitivity in posterior occlusal composite restorations.

Detailed Description
-----------------
The primary objective of this study is to observe the effect of gluma desensitizer application in controlling the post-treatment sensitivity in posterior occlusal composite restoration in molar teeth using 2 adhesive bonding strategies. The secondary objective is to evaluate the difference in the post-treatment sensitivity on application of Gluma desensitizer either prior to or after acid etching. The different adhesive gluma desensitizer application groups are randomly divided into 6 groups, Total etch control group (No gluma desensitizer application) Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching Self etch control group (No gluma desensitizer application) Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching

Official Title
-----------------
Efficacy of Gluma Desensitizer in Controlling the Immediate Post-treatment Sensitivity in Etch-and-rinse and Self-etch Adhesive Bonded Occlusal Composite Restorations

Conditions
-----------------
Sensitivity, Tooth

Intervention / Treatment
-----------------
* Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Occlusal cavitated caries in maxillary and mandibular first and second molars Exclusion Criteria: Occlusal caries with axial or proximal extension Teeth with periodontal treatment within last three months Teeth with cracks Teeth to be taken as abutment for prosthesis Patients with psychiatric treatment Patients in orthodontic treatment or going to need orthodontic treatment Patients under dentin hypersensitivity or using desensitizer treatment Patients not willing for post treatment follow up Patients having any other teeth with pain or sensitivity symptoms Caries excavation with pulp exposure and post treatment sensitivity due to occusal interference in restoration

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Total etch control group<br>No gluma desensitizer application | |
| Experimental: TE - GLUMA application prior to acid etching<br>TE- Total Etch GLUMA - Desensitizing agent | Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent<br>* GLUMA desensitizer is used to reduce tooth sensitivity<br>|
| Experimental: TE - GLUMA application after acid etching<br>TE- Total Etch GLUMA - Desensitizing agent | Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent<br>* GLUMA desensitizer is used to reduce tooth sensitivity<br>|
| No Intervention: Self etch control group<br>No gluma desensitizer application | |
| Experimental: SE - GLUMA application prior to acid etching<br>SE - Self Etch GLUMA - Desensitizing agent | Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent<br>* GLUMA desensitizer is used to reduce tooth sensitivity<br>|
| Experimental: SE - GLUMA application after acid etching<br>SE - Self Etch GLUMA - Desensitizing agent | Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent<br>* GLUMA desensitizer is used to reduce tooth sensitivity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative sensitivity | post-operative sensitivity is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe | 24 hours | 
| post-operative sensitivity | post-operative sensitivity is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe | 48 hours | 
| post-operative sensitivity | post-operative sensitivity is evaluated using Visual Analog Scale(VAS) and cold spray VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative sensitivity - stimulus based ( hot/cold) or spontaneous | post-operative sensitivity is either due to stimulus or spontaneous is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe | 24 hours | 
| post-operative sensitivity -stimulus based ( hot/cold) or spontaneous | post-operative sensitivity is either due to stimulus or spontaneous is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe | 48 hours | 
| post-operative sensitivity -stimulus based ( hot/cold) or spontaneous | post-operative sensitivity is either due to stimulus or spontaneous is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe | 1 week |