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

N/ANot Yet RecruitingNCT07005167
Cairo University54 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

54

Conditions

Endocrown Restoration

Interventions

endocrownsPROCEDURE

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

endocrownsPROCEDURE

endocrowns made of Cerasmart blocks to restore endo treated molars

Eligibility

Sex: ALLMin age: 21 Years
Medical Language ↔ Plain English
Inclusion Criteria: 1. Age ≥21 years 2. Good general health (ASA I or II) 3. Willing and able to provide informed consent 4. Committed to follow-up appointments for 18 months 5. Root canal treated molars requiring restoration 6. Adequate remaining tooth structure: * Minimum 2mm ferrule height * Sufficient wall thickness (≥1.5mm) * At least 2 remaining walls 7. Opposing natural dentition or fixed prosthesis 8. Adequate periodontal health: * Probing depth ≤4mm * No bleeding on probing 9. Good oral hygiene with plaque score ≤20% 10. Sufficient mouth opening for clinical procedures 11. Normal occlusion and acceptable interocclusal space Exclusion Criteria: 1. Pregnant or lactating women 2. Severe bruxism or parafunctional habits 3. Active periodontal disease 4. Active caries or inadequate oral hygiene 5. Less than 2mm ferrule height after preparation 6. Apical pathology or inadequate root canal treatment 7. Tooth mobility grade II or III 8. Known allergy to materials used 9. Uncontrolled diabetes (HbA1c \>7.0%) 10. Radiation therapy in head and neck region 11. Temporomandibular joint disorders 12. History of poor compliance with dental appointments 13. Heavy smokers (\>10 cigarettes/day) 14. Chronic use of medications affecting salivary flow 15. Unable to understand study requirements 16. Evidence of pulpal or periapical pathology

Locations (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Outcomes

Primary Outcomes

Retention

Modified USPHS criteria

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

Secondary Outcomes

Restoration Failure

Modified USPHS criteria

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

Marginal Adaptation

Modified USPHS criteria

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

Wear of Opposing Enamel

Digital software (Geomagic)

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

Surface Texture

Modified USPHS criteria

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

Color Match

Modified USPHS criteria

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

Luster of Restoration

Modified USPHS criteria

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

Patient Satisfaction

VAS (Questionnaire)

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

Central Contacts

Nada Farid Nada Farid Shehab, PhD

CONTACT

+201223402909nada.farid@dentistry.cu.edu.eg

Omnia Omnia Nabil, Lecturer Fixed Prosthodontics

CONTACT

+201222201179
Data from ClinicalTrials.gov

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