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NCT Number: NCT07005167

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location contact

Faculty of dentistry, cairo university

CONTACT

[email protected]

+223642705 ext. 543

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

endocrowns

Procedure

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

Primary outcomes

  1. Retention

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

    Modified USPHS criteria

Secondary outcomes

  1. Restoration Failure

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

    Modified USPHS criteria

  2. Marginal Adaptation

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

    Modified USPHS criteria

  3. Wear of Opposing Enamel

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

    Digital software (Geomagic)

  4. Surface Texture

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

    Modified USPHS criteria

  5. Color Match

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

    Modified USPHS criteria

  6. Luster of Restoration

    Time frame: From cementation, then at 6 months, 12 months and 18 months

    Modified USPHS criteria

  7. Patient Satisfaction

    Time frame: From cementation, then at 6 months, 12 months and 18 months

    VAS (Questionnaire)

Study contacts

Contact information is provided by the study sponsor or research team.

Nada Farid Nada Farid Shehab, PhD

CONTACT

[email protected]

+201223402909

Omnia Omnia Nabil, Lecturer Fixed Prosthodontics

CONTACT

+201222201179

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

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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