This Study is Conducted to Evaluate the Clinical Performance of Indirect Overlay Restorations With Different Cavity Preparation Designs in Endodontically Treated Molars.

NCT07614451 | Not Yet Recruiting

• 1 other identifier: 12041994
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is conducted to evaluate the clinical performance of indirect overlay restorations with different cavity preparation designs in endodontically treated molars over two years.

Conditions

Endodontically Treated Molar

Keywords

overlay; endodontically treated molars; biomimetic preparation

Outcome Measures

Primary Outcomes (1)

• Marginal adaptation (success rate)

  Measuring device: Modified FDI criteria, Measuring unit: Ordinal Data (scores)

  T0: baseline T1: 6 months T2: 12 months T3: 18 months T4: 2 years

Secondary Outcomes (1)

• proximal contact point 3.fracture of material and retention 4.wear 5. marginal staining 6. color match 7.caries at restoration margin

  T0: baseline T1: 6 months T2: 12 months T3: 18 months T4: 2 years

Study Arms (2)

conventional retentive overlay design

EXPERIMENTAL

Other: hybrid ceramic retentive overlay

minimal invasive non-retentive overlay design

EXPERIMENTAL

Other: hybrid ceramic non-retentive overlay

Interventions

hybrid ceramic retentive overlay OTHER

Endodontically treated molars will receive indirect overlay restorations utilizing a conventional retentive occlusal box cavity design.

conventional retentive overlay design

hybrid ceramic non-retentive overlay OTHER

Endodontically treated molars will receive indirect overlay restorations utilizing a minimal invasive anatomical non-retentive design.

minimal invasive non-retentive overlay design

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient Related Criteria:
• Adult patients (age: 20-60 years) of both genders.
• Healthy patients (not suffering of any systematic or chronic diseases).
• Able to tolerate the necessary restorative procedures.
• Willing to sign the informed ethical consent.
• Accepts the follow-up period.
• Tooth Related Criteria:
• Proper endodontically treated teeth.
• First and second permanent molars.
• Absence of any peri-apical lesions.
• Absence of any periodontal disease involvement.
• Large access cavities with one or two missing walls.
• Patients with proper oral hygiene.
• Presence of opposing tooth.

You may not qualify if:

• Patient related:
• Patients younger than 20 or older than 60 years old.
• Pregnant females.
• Patients with any systemic or chronic diseases.
• Patients not accepting the follow-up period.
• Patients not willing to sign the informed ethical consent.
• Patients with known allergies to latex and/or resinous material.
• Tooth related
• Endodontically treated anterior, premolar and third molar teeth.
• Hopelessly carious/destructed teeth necessitating extraction.
• Mobile teeth, indicating periodontal disease or trauma.
• External or internal resorption.
• Poor endodontic treatment.
• Periapical lesion present.
• Cervical carious lesions involved.

Sponsors & Collaborators

• Cairo University: lead

Study Officials

• Olfat ElSayed Hassanein, Professor

  Conservative Dentistry, Faculty of Dentistry, Cairo University

  STUDY DIRECTOR

Central Study Contacts

Sara Ibrahim Fahmy, PhD

CONTACT

01006256086; sara.fahmy@dentistry.cu.edu.eg

Aya Mohamed Adly, Lecturer

CONTACT

aya.mohamed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: part-time assistant lecturer

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 29, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): August 15, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share