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NCT Number: NCT07689032

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

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.

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Key information

Age range

22 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHOFU Hard blocks

Procedure

CAD/CAM Hybrid Ceramic, Overlay restored using the SHOFU cementation system.

BRILLIANT Crios

Procedure

Resin-based Composite, Overlay restored using the Coltène cementation system.

Primary outcomes

  1. Annual wear rate

    Time frame: 24 months

    Digital Scanner +Geometrical Subtraction Software

Secondary outcomes

  1. Functional properties, Biological properties and Esthetic properties

    Time frame: 24 months

    FDI Criteria

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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