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

NCT ID: NCT07005167

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endocrown Restoration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled, double-blind clinical trial with 1:1 allocation ratio.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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

Group Type EXPERIMENTAL

endocrowns

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

endocrowns

Intervention Type PROCEDURE

endocrowns made of Cerasmart blocks to restore endo treated molars

Interventions

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endocrowns

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

Intervention Type PROCEDURE

endocrowns

endocrowns made of Cerasmart blocks to restore endo treated molars

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Nada Ahmed Farid Zaki Shehab

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Nada Farid Nada Farid Shehab, PhD

Role: CONTACT

+201223402909

Omnia Omnia Nabil, Lecturer Fixed Prosthodontics

Role: CONTACT

+201222201179

Facility Contacts

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Faculty of dentistry, cairo university

Role: primary

+223642705 ext. 543

Other Identifiers

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Shofu Inc,

Identifier Type: OTHER

Identifier Source: secondary_id

240789

Identifier Type: -

Identifier Source: org_study_id

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