Carious MolarsNCT06820840
Hybrid Resin Composite vs. Hybrid Ceramic Onlays for Restoring Carious Molars
A study testing SHOFU Block HC Hard and SHOFU Ceramage in people with Carious Molars, run by Peter Medhat Youssef Gerges at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Carious Molars
- What is being tested?
- SHOFU Block HC Hard and SHOFU Ceramage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jul 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able to tolerate necessary restorative procedures
- Willing to sign the informed consent
- Accepts the follow-up period
Who cannot join
- ICDAS 4/5 cavities in first and second permanent molars
- Onlay cavities with at least one cusp coverage
- Patients with acceptable oral hygiene
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Vice Dean for Postgraduate Studies and Research, dentmail@dentistry.cu.edu.eg
About this study
Official title: 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?
Read more
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
- Being tested
- SHOFU Block HC Hard, SHOFU Ceramage
- Keywords
- Onlay, Onlays, Hybrid resin composite, Hybrid ceramic, SHOFU, Ceramage, S-PRG, SPRG, Vital molars, Block HC Hard
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHOFU Block HC HardOther
Cementation of hybrid ceramic onlay (SHOFU Block HC Hard) on carious molars.
SHOFU CeramageOther
Cementation of hybrid resin composite onlay (SHOFU Ceramage) on carious molars.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Ceramic Onlay | Active comparator | Not described Receives: Other: SHOFU Block HC Hard |
| Hybrid Resin Composite Onlay | Experimental | Not described Receives: Other: SHOFU Ceramage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Performance
Measured using modified USPHS criteria
Measured: From baseline to 18 months
Secondary outcomes (1)
Quantitative Wear Analysis
Measured in micrometers (μm) using a three-dimensional surface-based superimposition software
Measured: From baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start22 Jul 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious MolarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Medhat Youssef Gerges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Medhat Youssef Gerges, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820840
- Sponsor's protocol ID
- PGCU-6-2-2025
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Performance of Hybrid Resin Composite vs. Hybrid Ceramic Onlays in the Restoration of Carious Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06820840
- Acronym / sponsor ID
- PGCU-6-2-2025
- Conditions
- Carious Molars
- Keywords
- Onlay, Onlays, Hybrid resin composite, Hybrid ceramic, SHOFU, Ceramage, S-PRG, SPRG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Peter Medhat Youssef GergesUniversity, hospital or other
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid Ceramic Onlay | Active comparator | Other: SHOFU Block HC Hard |
| Hybrid Resin Composite Onlay | Experimental | Other: SHOFU Ceramage |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Able to tolerate necessary restorative procedures
- Willing to sign the informed consent
- Accepts the follow-up period
Key exclusion criteria (3 listed)
- ICDAS 4/5 cavities in first and second permanent molars
- Onlay cavities with at least one cusp coverage
- Patients with acceptable oral hygiene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHOFU Block HC HardCementation of hybrid ceramic onlay (SHOFU Block HC Hard) on carious molars. | Other | Hybrid Ceramic Onlay |
| SHOFU CeramageCementation of hybrid resin composite onlay (SHOFU Ceramage) on carious molars. | Other | Hybrid Resin Composite Onlay |
Primary outcome
Clinical Performance
Time frame: From baseline to 18 months
Measured using modified USPHS criteria
1 secondary outcome
Quantitative Wear Analysis
Time frame: From baseline to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: Yes. Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
Related trials for Carious Molars
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical and Radiographic Comparison of SMART Hall and Conventional Hall Techniques in Children With Carious Primary Molars
Clinical Effect
Active, not recruiting
Total Pulpotomy With Two Repair Cements in Hypomineralized Teeth
Molar-Incisor Hypomineralization (MIH)
Active, not recruiting
Pulpotomy in Hypominerlized Permanent Molars.
Molar Hypomineralization
Not yet recruiting
Oxymetazoline Versus Sodium Hypochlorite as Hemostatic Agents in MTA Pulpotomy of Primary Molars
Pulp Disease, Dental, Pulp Therapy in Primary Molars
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHOFU Block HC Hard and SHOFU Ceramage in people with Carious Molars, run by Peter Medhat Youssef Gerges at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter M Gerges, MSc in Restorative Dentistry (+201098724341, peter.medhat@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Performance (time frame: From baseline to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.