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

Not Applicable

Active, not recruiting

• Conditions: Dental Caries

• 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

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