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

March 31, 2026 updated by: Peter Medhat Youssef Gerges

Comparative Clinical Performance of Hybrid Resin Composite vs. Hybrid Ceramic Onlays in the Restoration of Carious Molars: A Randomized Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hybrid Ceramic Onlay
Other: SHOFU Block HC Hard
Cementation of hybrid ceramic onlay (SHOFU Block HC Hard) on carious molars.
Experimental: Hybrid Resin Composite Onlay
Other: SHOFU Ceramage
Cementation of hybrid resin composite onlay (SHOFU Ceramage) on carious molars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Performance
Time Frame: From baseline to 18 months
Measured using modified USPHS criteria
From baseline to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative Wear Analysis
Time Frame: From baseline to 18 months
Measured in micrometers (μm) using a three-dimensional surface-based superimposition software
From baseline to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter Medhat Youssef Gerges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

February 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PGCU-6-2-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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