Clinical Performance Of Conserved Chalky White Demineralized Enamel Cavity Margins Versus Totally Removed Carious Margins In Class V Cavities Restored With Composite Resin

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the clinical performance of conserved chalky white demineralized enamel margins with total removal of demineralized enamel margins in class v cavities restored with composite in patients with acute carious cervical lesions

Detailed Description
-----------------
With limited evidence-based information about the clinical performance of conserved white chalky enamel margins in class v .it is beneficial to compare the newly concept of preserved the white chalky deminerlized enamel margins using a randomized clinical trial to test the null hypothesis that this new concept has the same clinical performance as total removal of demineralized enamel margins in class v cavities restored with composite in patients with acute carious cervical lesions .The comparator will be the concept of total removal of demineralized enamel margins in class v cavities restored with composite Patients are selected according to the eligibility criteria, Local anesthesia will be administered and the operative field will be isolated before starting the restorative procedure. For the comparator group, standard class V cavities will be prepared at labial surface with totally removed carious enamel margins. For interventional group, class V cavity prepared at labial surface with preserved the chalky demineralized enamel margins then applications of remineralizing agent(MI paste plus) before the application of resin composite restoration. Local anesthesia will be administered and the operative field will be isolated before starting the restorative procedure. For control group, standard class V cavities will be prepared at labial surface with totally removed carious enamel margins. For experimental group, class V cavity prepared at labial surface with preserved the chalky demineralized enamel margins then applications of remineralizing agent(MI paste plus) before the application of resin composite restoration. both cavities groups restored with resin composite restorations. The restorations are assessed using the modified USPHS criteria at the time intervals stated in the outcome measures

Official Title
-----------------
Clinical Performance Of Conserved Chalky White Demineralized Enamel Cavity Margins Versus Totally Removed Carious Margins In Class V Cavities Restored With Composite Resin

Conditions
-----------------
Class V Dental Caries

Intervention / Treatment
-----------------
* Procedure: conserved chalky white enamel margins of class V cavities
* Procedure: Total removal of demineralized enamel margins of class V cavities


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: class V carious lesions in premolars and molars. Vital upper or lower teeth with no signs of irreversible pulpitis. Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth. Exclusion Criteria: Deep carious defects (close to pulp, less than 1 mm distance). Periapical pathology or signs of pulpal pathology. Endodontically treated teeth Tooth hypersensitivity. Possible prosthodontic restoration of teeth. Heavy occlusion or occlusal contacts or history of bruxism. Severe periodontal affection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conservation of the demineralized chalky white enamel margin of class V cavities<br>for cavity design in this arm we Conserved the demineralized chalky white enamel margin of class V cavities then application of resin composite restoration | Procedure: conserved chalky white enamel margins of class V cavities<br>* during cavity preparation, we conserved chalky white enamel margins of class V cavities and then restored them with resin composite restorations,we assessed the restorations with visual inspection using a mirror and explorer according to USPHS Criteria<br>|
| Active Comparator: Total removal of demineralized enamel margin of class V cavities<br>for cavity design in this arm is Total removal of demineralized enamel margin of class V cavities and restoration with resin composite | Procedure: Total removal of demineralized enamel margins of class V cavities<br>* during cavity preparation, we removed the total chalky white enamel margins of class V cavities and then restored them with resin composite restorations, we assessed the restorations with visual inspection using a mirror and explorer according to USPHS Criteria<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| marginal discoloration | ordinal criteria scoring system (ordinal) | 3 months | 
| marginal discoloration | ordinal criteria scoring system (ordinal) | 6 months | 
| marginal discoloration | ordinal criteria scoring system (ordinal) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| color change | ordinal criteria scoring system (ordinal) | 3 month | 
| color change | ordinal criteria scoring system (ordinal) | 6 month | 
| color change | ordinal criteria scoring system (ordinal) | 12 month |