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Not yet recruiting NCT07005167

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

No phase Interventional Endocrown Restoration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: endocrowns, endocrowns.
Who it may be relevant to
Registry conditions: Endocrown Restoration. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Procedure endocrowns
    endocrowns made of HC hard blocks or cerasmart blocks to restore endo treated molars
  • Procedure endocrowns
    endocrowns made of Cerasmart blocks to restore endo treated molars

Primary outcome measures

  • Retention [Time frame: From cementation of endocrown, then at 6 months, 12 months and 18 months]
Secondary outcome measures (7)
  • Restoration Failure [Time frame: From cementation of endocrown, then at 6 months, 12 months and 18 months]
  • Marginal Adaptation [Time frame: From cementation of endocrown, then at 6 months, 12 months and 18 months]
  • Wear of Opposing Enamel [Time frame: From cementation of endocrown, then at 6 months, 12 months and 18 months]
  • Surface Texture [Time frame: From cementation of endocrown, then at 6 months, 12 months and 18 months]
  • Color Match [Time frame: From cementation of endocrown, then at 6 months, 12 months and 18 months]
  • Luster of Restoration [Time frame: From cementation, then at 6 months, 12 months and 18 months]
  • Patient Satisfaction [Time frame: From cementation, then at 6 months, 12 months and 18 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry, Cairo University — Cairo

Identifiers

NCT: NCT07005167 · 240789 · Shofu Inc,

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗