Hybrid Resin Composite vs. Hybrid Ceramic Onlays for Rest... | NCT06820840

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

NCT06820840

Sponsor

Peter Medhat Youssef Gerges

Status

Recruiting

Last Update Posted

Apr 6, 2026Actual

Enrollment

64Estimated

Phase

Not Applicable

Conditions

Carious Molars

Interventions

SHOFU Block HC Hard
SHOFU Ceramage

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 22, 2025Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Feb 6, 2025

First Submission Date that Met QC Criteria

Feb 6, 2025

First Posted Date

Feb 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2026

Last Update Posted Date

Apr 6, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter Medhat Youssef Gerges, Assistant Lecturer - Conservative Dentistry Department - MIU, Cairo UniversitySponsor-Investigator

Lead Sponsor

Peter Medhat Youssef GergesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hybrid Ceramic Onlay	Active Comparator		Other: SHOFU Block HC Hard
Hybrid Resin Composite Onlay	Experimental		Other: SHOFU Ceramage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SHOFU Block HC Hard	Other	Cementation of hybrid ceramic onlay (SHOFU Block HC Hard) on carious molars.	Hybrid Ceramic Onlay

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peter M Gerges, MSc in Restorative Dentistry	Contact	+201098724341		peter.medhat@dentistry.cu.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

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

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided