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

NCT07005167 | Not Yet Recruiting

• 2 other identifiers: 240789Shofu Inc,
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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. 1.To compare the incidence of restoration failures between the two materials
2. 2.To assess marginal adaptation and marginal discoloration over time
3. 3.To evaluate wear of opposing enamel quantitatively
4. 4.To compare surface texture, color match, and luster between materials
5. 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.

Conditions

Endocrown Restoration

Keywords

Hybrid ceramics; cerasmart; HC hard blocks

Outcome Measures

Primary Outcomes (1)

• Retention

  Modified USPHS criteria

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

Secondary Outcomes (7)

• Restoration Failure

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

• 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

Study Arms (2)

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

EXPERIMENTAL

Procedure: endocrowns

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

ACTIVE COMPARATOR

Procedure: endocrowns

Interventions

endocrowns PROCEDURE

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

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

Central Study Contacts

Nada Farid Nada Farid Shehab, PhD

CONTACT

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

Omnia Omnia Nabil, Lecturer Fixed Prosthodontics

CONTACT

+201222201179

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Randomized, controlled, double-blind clinical trial with 1:1 allocation ratio.

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 5, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-05

Locations

EG (1)