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

Not Applicable

Active, not recruiting

• Conditions: Dental Caries
• Interventions: Procedure: Low shrinkage Flowable Composite (cervical margin relocation); Procedure: Highly viscous glass ionomer (cervical margin relocation); Procedure: Bioactive Ionic Resin (cervical margin relocation); Procedure: Resin Modified Glass Ionomer (cervical margin relocation)

• Registration Number: NCT06155773
• Lead Sponsor: Mansoura University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-24
• Primary Completion: 2022-01-05
• Status Verified: 2023-05
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-12-02
• Last Update Submitted: 2023-12-03
• Study First Posted: 2023-12-04
• Last Update Posted: 2023-12-08
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low shrinkage Flowable Composite	Low shrinkage Flowable Composite (cervical margin relocation)	Low shrinkage Flowable Composite restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration
Highly viscous Glass Ionomer	Highly viscous glass ionomer (cervical margin relocation)	Highly viscous glass ionomer restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration
Bioactive Ionic Resin	Bioactive Ionic Resin (cervical margin relocation)	Bioactive Ionic Resin restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration
Resin Modified Glass Ionomer	Resin Modified Glass Ionomer (cervical margin relocation)	Resin Modified Glass Ionomer restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration

Primary Outcome Measures

Name	Time	Method
Modified World Dental Federation (FDI) clinical Criteria	three year follow up	1. Functional Properties of restorations: 1. Fracture of material and retention; 2. Marginal adaptation; 3. Radiographic examination; 2. Biological Properties of restorations; 1. Postoperative (hyper-sensitivity and tooth vitality; 2. Recurrence of caries; 3. Tooth integrity (enamel cracks, tooth fractures); 4. Periodontal Response; 5. 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
Gingiva	three year follow up	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

Trial Locations

Locations (1)

Faculty of dentistry , Mansoura University; 🇪🇬 Mansoura, Dakahlia, Egypt