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Completed

NCT Number: NCT07265609

Clinical Performance of Two Different Resin-Matrix Ceramic Restorations

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahliya, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • The buccolingual width of lesions should exceed two-thirds of the intercuspal distance.
  • The teeth were required to be vital and free from any periapical radiolucency.
  • 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

  • The presence of uncontrolled systemic disease, pregnancy or breastfeeding.
  • Patients with extremely poor oral hygiene, active periodontal disease, or those involving in orthodontic treatment or periodontal surgery.
  • Patients with wear facets and parafunctional habits as clinching and bruxism.
  • Hypersensitive, endodontically treated, non-vital or cracked teeth.
  • 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.
  • Teeth without proximal contact, missing neighbouring or opposing teeth
  • Patients with known unavailability to attend recall visits, or with known allergy to any component of the study materials.

Treatment and study plan

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.

Other names: Indirect restorations, partial-coverage restorations

Primary outcomes

  1. Esthetic, functional and biological properties for each CAD/CAM restorative material

    Time frame: 2 years

    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.

Secondary outcomes

  1. Radiographic examination

    Time frame: 2 years

    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. Periodontal response and adjacent mucosa

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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