Hybrid Resin Composite vs. Hybrid Ceramic Onlays for Restoring Carious Molars

NCT06820840 | Recruiting

• 1 other identifier: PGCU-6-2-2025
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the clinical performance of hybrid resin composite and hybrid ceramic onlays in restoring carious molars. It will also evaluate the wear resistance of both materials. The main questions it aims to answer are:

• Does the hybrid resin composite or hybrid ceramic onlay perform better in clinical settings over time?
• How much wear occurs in each type of onlay over 18 months? Researchers will compare SHOFU Ceramage (hybrid resin composite) to SHOFU Block HC Hard(hybrid ceramic) to see which material performs better in restoring molars with extensive caries. Participants will:
• Receive either a hybrid resin composite or hybrid ceramic onlay for their molar cavities.
• Visit the clinic for checkups at baseline, 6 months, 12 months, and 18 months.
• Undergo visual assessments of their restorations and quantitative wear analysis during follow-ups.

Conditions

Carious Molars

Keywords

Onlay; Onlays; Hybrid resin composite; Hybrid ceramic; SHOFU; Ceramage; S-PRG; SPRG; Vital molars; Block HC Hard

Outcome Measures

Primary Outcomes (1)

• Clinical Performance

  Measured using modified USPHS criteria

  From baseline to 18 months

Secondary Outcomes (1)

• Quantitative Wear Analysis

  From baseline to 18 months

Study Arms (2)

Hybrid Ceramic Onlay

ACTIVE COMPARATOR

Other: SHOFU Block HC Hard

Hybrid Resin Composite Onlay

EXPERIMENTAL

Other: SHOFU Ceramage

Interventions

SHOFU Block HC Hard OTHER

Cementation of hybrid ceramic onlay (SHOFU Block HC Hard) on carious molars.

Hybrid Ceramic Onlay

SHOFU Ceramage OTHER

Cementation of hybrid resin composite onlay (SHOFU Ceramage) on carious molars.

Hybrid Resin Composite Onlay

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Able to tolerate necessary restorative procedures
• Willing to sign the informed consent
• Accepts the follow-up period

You may not qualify if:

• ICDAS 4/5 cavities in first and second permanent molars
• Onlay cavities with at least one cusp coverage
• Patients with acceptable oral hygiene

Sponsors & Collaborators

• Peter Medhat Youssef Gerges: lead

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

Central Study Contacts

Peter M Gerges, MSc in Restorative Dentistry

CONTACT

+201098724341; peter.medhat@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer - Conservative Dentistry Department - MIU

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

EG (1)