Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study was designed to evaluate and compare the 2-year clinical performance of two different resin-matrix ceramic inlays
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resin nano-ceramic | Active Comparator | 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. |
|
| Polymer-infiltrated ceramics | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inlays | Other | 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. |
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hanan Fathy, Assistant Lecturer | Faculty of Dentistry, Mansoura University, Egypt | Principal Investigator |
| 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 Director |
| Salah H Mahmoud, Clinical Professor | Faculty of Dentistry, Mansoura Universtity, Egypt | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Mansoura University | Al Mansurah | Dakahliya | 35516 | Egypt |
Not provided
Data will be available within 6 months for 3 years
for anyone
Not provided
Not provided
| ID | Term |
|---|---|
| D007284 | Inlays |
| ID | Term |
|---|---|
| D003793 | Dental Restoration, Permanent |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
| D003813 | Dentistry |
Not provided
Not provided
The study is a randomized split-mouth clinical trial. Each participant received both restorative materials: a resin-nanoceramic and a polymer-infiltrated ceramic. Randomization assigned one material to one side of the mouth and the other material to the contralateral side for each participant. Treatments were applied according to the manufacturers' instructions.
Not provided
Not provided
Not provided
|
|
| 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 |
| D019736 |
| Prostheses and Implants |
| D004864 | Equipment and Supplies |