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Clinical Trials/NCT07005167
NCT07005167Not yet recruitingNot Applicable

Clinical Performance of Endocrowns Fabricated From Two Hybrid Ceramic Materials on Endodontically Treated Molars: A Randomized Clinical Trial

Cairo University1 site in 1 country54 target enrollmentStarted: June 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
54
Locations
1
Primary Endpoint
Retention

Study Overview

Brief Summary

The goal of this study is to evaluate the clinical success rate (measured by retention) of endo-crowns fabricated from two hybrid ceramic materials (HC Hard blocks ) versus (Cerasmart) at 6, 12, and 18 months.

Secondary Objectives are:

  1. To compare the incidence of restoration failures between the two materials
  2. To assess marginal adaptation and marginal discoloration over time
  3. To evaluate wear of opposing enamel quantitatively
  4. To compare surface texture, color match, and luster between materials
  5. To determine patient satisfaction with both types of restorations It will be a randomized, controlled, double-blind clinical trial with 1:1 allocation ratio.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age ≥21 years
  • •Good general health (ASA I or II)
  • •Willing and able to provide informed consent
  • •Committed to follow-up appointments for 18 months
  • •Root canal treated molars requiring restoration
  • •Adequate remaining tooth structure:
  • •Minimum 2mm ferrule height
  • •Sufficient wall thickness (≥1.5mm)
  • •At least 2 remaining walls
  • •Opposing natural dentition or fixed prosthesis
  • •Adequate periodontal health:
  • •Probing depth ≤4mm
  • •No bleeding on probing
  • •Good oral hygiene with plaque score ≤20%
  • •Sufficient mouth opening for clinical procedures
  • •Normal occlusion and acceptable interocclusal space

Exclusion Criteria

  • •Pregnant or lactating women
  • •Severe bruxism or parafunctional habits
  • •Active periodontal disease
  • •Active caries or inadequate oral hygiene
  • •Less than 2mm ferrule height after preparation
  • •Apical pathology or inadequate root canal treatment
  • •Tooth mobility grade II or III
  • •Known allergy to materials used
  • •Uncontrolled diabetes (HbA1c >7.0%)
  • •Radiation therapy in head and neck region
  • •Temporomandibular joint disorders
  • •History of poor compliance with dental appointments
  • •Heavy smokers (>10 cigarettes/day)
  • •Chronic use of medications affecting salivary flow
  • •Unable to understand study requirements
  • •Evidence of pulpal or periapical pathology

Arms & Interventions

utpatients with endo-treated molars that will be restored with Cerasmart endocrowns

Active Comparator

Intervention: endocrowns (Procedure)

Outpatients with endo-treated molars that will be restored with HC hard hybrid ceramic endocrowns

Experimental

Intervention: endocrowns (Procedure)

Outcomes

Primary Outcomes

Retention

Time Frame: From cementation of endocrown, then at 6 months, 12 months and 18 months

Modified USPHS criteria

Secondary Outcomes

  • Marginal Adaptation(From cementation of endocrown, then at 6 months, 12 months and 18 months)
  • Wear of Opposing Enamel(From cementation of endocrown, then at 6 months, 12 months and 18 months)
  • Surface Texture(From cementation of endocrown, then at 6 months, 12 months and 18 months)
  • Color Match(From cementation of endocrown, then at 6 months, 12 months and 18 months)
  • Luster of Restoration(From cementation, then at 6 months, 12 months and 18 months)
  • Patient Satisfaction(From cementation, then at 6 months, 12 months and 18 months)
  • Restoration Failure(From cementation of endocrown, then at 6 months, 12 months and 18 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nada Ahmed Farid Zaki Shehab

Lecturer

Cairo University

Study Sites (1)

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