- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SHOFU Hard blocks
CAD/CAM Hybrid Ceramic, Overlay restored using the SHOFU cementation system.
|
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.
|
Resin-based Composite, Overlay restored using the Coltène cementation system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Annual wear rate
Time Frame: 24 months
|
Digital Scanner +Geometrical Subtraction Software
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional properties, Biological properties and Esthetic properties
Time Frame: 24 months
|
FDI Criteria
|
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 261292
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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