Clinical Performance of Two Different Resin-Matrix Ceramic Restorations

A Two-year Comparative Evaluation of Clinical Performance of a CAD/CAM Composite to a Polymer-infiltrated Ceramic Restorations

This study was designed to evaluate and compare the 2-year clinical performance of two different resin-matrix ceramic inlays

Study Overview

• Status: Completed
• Conditions: Dental Restoration Failure
• Intervention / Treatment: Other: inlays

Detailed Description

The design of this prospective randomized controlled clinical trial was a split-mouth, two-arm, double-blinded clinical trial, with an allocation ratio of 1:1. The reporting of the trial followed the Consolidated Standards of Reporting Trials (CONSORT) Statement. Twelve adult patients seeking dental treatments in the Conservative Dentistry Department outpatient clinic, Faculty of Dentistry, Mansoura University, were enrolled in the current study with a total of twenty-four compound inlay cavities. Each patient must sign a consent form before participating in the current study. The study was conducted from August 2023 to August 2025 as a part of the doctoral dissertation. Mansoura University's institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated using the G*Power statistical program. Based on an effect size of 0.4, a significance level of 5% (p < 0.05), and a statistical power of 80%, a minimum of 10 samples per group was required. To compensate for potential dropouts, the total sample size was increased to 12 patients, yielding a total of 24 restorations.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahliya
    • Al Mansurah, Dakahliya, Egypt, 35516
      • Faculty of Dentistry, Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. The presence of two molars with compound proximal carious lesions or defective restorations involving two surfaces (occluso-mesial or occluso-distal cavities) corresponding to Black's Class II, with a severity score of 4 or 5 according to the International Caries Detection and Assessment System (ICDAS)
2. The buccolingual width of lesions should exceed two-thirds of the intercuspal distance.
3. The teeth were required to be vital and free from any periapical radiolucency.
4. The teeth were required to be in normal alignment, in contact with sound adjacent teeth, and have antagonist teeth present in normal occlusion.

Exclusion Criteria:

1. The presence of uncontrolled systemic disease, pregnancy or breastfeeding.
2. Patients with extremely poor oral hygiene, active periodontal disease, or those involving in orthodontic treatment or periodontal surgery.
3. Patients with wear facets and parafunctional habits as clinching and bruxism.
4. Hypersensitive, endodontically treated, non-vital or cracked teeth.
5. Teeth with proximal cavities involving more than two surfaces, those that exhibited pulp exposure during caries excavation and required direct pulp capping, or those with missing cusps necessitating cusp capping.
6. Teeth without proximal contact, missing neighbouring or opposing teeth
7. Patients with known unavailability to attend recall visits, or with known allergy to any component of the study materials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Resin nano-ceramic; Resin-matrix ceramic CAD/CAM blocks for indirect restorations. Restorations were designed, milled, finished, and cemented on the assigned contralateral site according to the manufacturer's instructions. Each patient received this material on one side of the mouth; side allocation was randomized.	Other: inlays; Inlay cavity preparations were performed, and RMC restorations were designed, milled, finished, and cemented on the assigned contralateral site according to the manufacturer's instructions. Each patient received one material on one side of the mouth and the other on the contralateral side. Side allocation was randomized.; Other Names: Indirect restorations; partial-coverage restorations
Active Comparator: Polymer-infiltrated ceramics; Resin-matrix ceramic CAD/CAM blocks for indirect restorations. Restorations were designed, milled, finished, and cemented on the assigned contralateral site according to the manufacturer's instructions. Each patient received this material on one side of the mouth; side allocation was randomized.	Other: inlays; Inlay cavity preparations were performed, and RMC restorations were designed, milled, finished, and cemented on the assigned contralateral site according to the manufacturer's instructions. Each patient received one material on one side of the mouth and the other on the contralateral side. Side allocation was randomized.; Other Names: Indirect restorations; partial-coverage restorations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Esthetic, functional and biological properties for each CAD/CAM restorative material	Esthetic, functional and biological properties were assessed using World Dental Federation (FDI) criteria. Each criterion was rated on a five-point scale, where a score of 1 indicated clinically excellent or very good performance, score 2 indicated clinically good, score 3 indicated a clinically satisfactory, score 4 indicated clinically unsatisfactory, and score 5 indicated clinically poor performance requiring repair or replacement.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic examination	Each material was examined radiographically and radiographs were assessed and rated following World Dental Federation (FDI) five-point scale, where a score of 1 indicated clinically excellent or very good performance, score 2 indicated clinically good, score 3 indicated a clinically satisfactory, score 4 indicated clinically unsatisfactory, and score 5 indicated clinically poor performance requiring repair or replacement.	2 years
Periodontal response and adjacent mucosa	Periodontal responce and adjacent mucosa were assessed using World Dental Federation (FDI) criteria. Each criterion was rated on a five-point scale, where a score of 1 indicated clinically excellent or very good performance, score 2 indicated clinically good, score 3 indicated a clinically satisfactory, score 4 indicated clinically unsatisfactory, and score 5 indicated clinically poor performance requiring repair or replacement.	2 years

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Hanan Fathy, Assistant Lecturer, Faculty of Dentistry, Mansoura University, Egypt; Study Director: Hamdi Hamama, Clinical Professor, Faculty of Dentistry, Mansoura Universtity, Egypt; Study Director: Jukka P Matinlinna, Clinical Professor, School of Medical Science, University of Manchester, M13 9PL, Manchester, UK; Study Chair: Salah H Mahmoud, Clinical Professor, Faculty of Dentistry, Mansoura Universtity, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): August 1, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: CAD/CAM; Resin-matrix ceramics; Polymer-infiltrated ceramics; Resin nano-ceramics; Indirect restorations
• Additional Relevant MeSH Terms: Equipment and Supplies; Prostheses and Implants; Dentistry; Dental Prosthesis; Prosthodontics; Dental Restoration, Permanent; Inlays
• Other Study ID Numbers: J0022055023CD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Data will be available within 6 months for 3 years
• IPD Sharing Access Criteria: for anyone
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No