Clinical Performance of Two Different Resin-Matrix Ceramic Restorations

NCT07265609 | Completed

• 1 other identifier: J0022055023CD
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Restoration Failure

Keywords

Resin-matrix ceramics; Polymer-infiltrated ceramics; Resin nano-ceramics; Indirect restorations; CAD/CAM

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Radiographic examination

  2 years

• Periodontal response and adjacent mucosa

  2 years

Study Arms (2)

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.

Other: inlays

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.

Other: inlays

Interventions

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.

Also known as: Indirect restorations, partial-coverage restorations

Polymer-infiltrated ceramics; Resin nano-ceramic

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahliya, 35516, Egypt

Location

MeSH Terms

Interventions

Inlays

Intervention Hierarchy (Ancestors)

Dental Restoration, Permanent; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 5, 2025
• Study Start: August 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available within 6 months for 3 years
• Access Criteria: for anyone

Locations

EG (1)