Evaluation of Wear Resistance of CAD/CAM Hybrid Ceramic and Nano-Hybrid Composite Overlays in Endodontically Treated Molars and Their Effect on Natural Antagonist Teeth

June 30, 2026 updated by: Sara Salem Sayed Ahmed, Cairo University

Evaluation of Wear Resistance of CAD/CAM Hybrid Ceramic and Nano-Hybrid Composite Overlays in Endodontically Treated Molars and Their Effect on Natural Antagonist Teeth: A 24-Month Randomized Clinical Trial

This randomized clinical trial aims to to evaluate and compare the 24-month surface wear of the restoration and the surface wear of the opposing natural tooth structure of CAD/CAM Hybrid Ceramic (SHOFU Hard blocks) versus Resin-based Composite (BRILLIANT Crios) overlays, utilizing a digital subtraction methodology (Intraoral Scanner and Geometrical Subtraction Software) in endodontically treated molar teeth.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The rationale for this 24-month RCT is driven by the need for high-level, evidence-based data to guide clinical material selection for compromised teeth. This trial is designed to directly compare two materials specifically engineered to be stress-absorbing in the oral environment. The primary intervention, the SHOFU Restorative System (Hard blocks), is a Hybrid Ceramic engineered to combine the durability of ceramics with the elasticity of polymers. Its reduced hardness and dentin-like modulus allow for rapid machining and are associated with reduced antagonist abrasion compared to conventional ceramics. The second material, serving as the comparator, is the Coltène Restorative System (BRILLIANT Crios), which is a reinforced nano-hybrid composite characterized by an elastic modulus comparable to dentin, designed for optimal shock absorption and confirmed to be gentle on antagonist teeth.

Focusing the study on endodontically treated molars addresses a highly prevalent clinical scenario where maximizing the longevity of the restoration and the remaining tooth structure is paramount. The use of a full-cusp-coverage overlay design represents the maximum conservation approach for these compromised teeth while ensuring that the selected restorative materials do not exert harmful effects on opposing dentition.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 22 and 45 years.
  • Low to moderate caries risk.
  • Normal occlusion.
  • Absence of signs or symptoms of temporomandibular joint (TMJ) disorders.
  • Satisfactory oral hygiene.
  • Medically fit to receive routine restorative dental treatment.
  • Permanent molars.
  • Asymptomatic endodontically treated teeth.
  • Homogeneous root canal fillings extending 1-2 mm from the radiographic apex.
  • Compound cavities.
  • Favorable occlusion.
  • Presence of both an adjacent tooth and a sound opposing tooth in occlusion

Exclusion Criteria:

  • * Presence of bruxism.

    • Poor patient cooperation.
    • Inability or unwillingness to attend follow-up appointments.
    • Anticipated travel during the study period.
    • Poor oral hygiene.
    • Chronic or advanced periodontitis.
    • Known allergies to any of the materials used in the study.
    • Patients who are pregnant or breastfeeding.
    • Teeth with <1" mm" of residual wall thickness.
    • Deep subgingival cavity margins.
    • Severe periodontal problems.
    • Radiographic signs of apical pathology.

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SHOFU Hard blocks
CAD/CAM Hybrid Ceramic, Overlay restored using the SHOFU cementation system.
Procedure: SHOFU Hard blocks
CAD/CAM Hybrid Ceramic, Overlay restored using the SHOFU cementation system.
Active Comparator: BRILLIANT Crios
Resin-based Composite, Overlay restored using the Coltène cementation system.
Procedure: BRILLIANT Crios
Resin-based Composite, Overlay restored using the Coltène cementation system.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Annual wear rate
Time Frame: 24 months
Digital Scanner +Geometrical Subtraction Software
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional properties, Biological properties and Esthetic properties
Time Frame: 24 months
FDI Criteria
24 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 261292

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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