Clinical Performance of Onlay Restorations After Cervical Margin Relocation (CMR)

Study Overview
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Brief Summary
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The current study intends to evaluate the effect of cervical margin relocation with different restorative materials on three-year clinical performance of indirect Computer-Aided-Design (CAD)/ Computer-Aided-Manufacture (CAM) onlay restorations. This study is designed to test the null hypothesis that the three-year clinical performance of onlay restorations is significantly affected by cervical margin relocation with different restorative materials.

Official Title
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Effect of Cervical Margin Relocation With Different Restorative Materials on Three-year Clinical Performance and In-Vitro Fracture Resistance of Indirect Hybrid Ceramic Onlay Restorations

Conditions
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Dental Caries

Intervention / Treatment
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* Procedure: Highly viscous glass ionomer (cervical margin relocation)
* Procedure: Low shrinkage Flowable Composite (cervical margin relocation)
* Procedure: Resin Modified Glass Ionomer (cervical margin relocation)
* Procedure: Bioactive Ionic Resin (cervical margin relocation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general health Good oral hygiene Patient aging 20-40 y Patients with proximal deep carious lesion International caries detection and assessment system (ICDAS) 4 or 5 that diagnosed clinically and radiographically. Normal response to a vitality test. Exclusion Criteria: poor general health poor oral hygiene Teeth would need direct pulp capping Teeth act as abutment for fixed or removable prosthesis. patients with excessive parafunctional habits Patient potentially unable to be compliant to recall visits

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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: Highly viscous Glass Ionomer<br>Highly viscous glass ionomer restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration | Procedure: Highly viscous glass ionomer (cervical margin relocation)<br>* different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations<br>|
| Experimental: Low shrinkage Flowable Composite<br>Low shrinkage Flowable Composite restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration | Procedure: Low shrinkage Flowable Composite (cervical margin relocation)<br>* different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations<br>|
| Experimental: Resin Modified Glass Ionomer<br>Resin Modified Glass Ionomer restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration | Procedure: Resin Modified Glass Ionomer (cervical margin relocation)<br>* different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations<br>|
| Experimental: Bioactive Ionic Resin<br>Bioactive Ionic Resin restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration | Procedure: Bioactive Ionic Resin (cervical margin relocation)<br>* different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingiva | Gingival Index Scale from 0 to 3 will be used for evaluation considering that score 0 represents normal gigiva while score 3 represents severely inflamed gingiva | three year follow up | 
| Modified World Dental Federation (FDI) clinical Criteria | Functional Properties of restorations: Fracture of material and retention Marginal adaptation Radiographic examination Biological Properties of restorations Postoperative (hyper-sensitivity and tooth vitality Recurrence of caries Tooth integrity (enamel cracks, tooth fractures) Periodontal Response Adjacent mucosa Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor. Scores(1-3) are considered sufficient The overall cumulative success rate of restorations will be evaluated | three year follow up |