NCT07689032

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
23mo left

Started Jul 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Jul 2026Jul 2028

First Submitted

Initial submission to the registry

June 30, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

June 30, 2026

Last Update Submit

June 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Annual wear rate

    Digital Scanner +Geometrical Subtraction Software

    24 months

Secondary Outcomes (1)

  • Functional properties, Biological properties and Esthetic properties

    24 months

Study Arms (2)

SHOFU Hard blocks

EXPERIMENTAL

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

Procedure: SHOFU Hard blocks

BRILLIANT Crios

ACTIVE COMPARATOR

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

Procedure: BRILLIANT Crios

Interventions

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

SHOFU Hard blocks

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

BRILLIANT Crios

Eligibility Criteria

Age22 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \* 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth Attrition

Condition Hierarchy (Ancestors)

Tooth WearTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 7, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

July 7, 2026

Record last verified: 2026-06