Assessment of Marginal and Internal Fit of High Performance Polymer PEEK Endocrown Using Two Preparation Designs

NCT06500845 | Recruiting

• 1 other identifier: 3324
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

First, Participants in this study will be recruited according to inclusion criteria. Proper examination for the participants (clinically and radiographically). Preparation for endodontically treated molar for receiving high performance polymer endocrown. Checking and verification for the restoration (trying) and assessment of marginal and internal fit by replica technique. Then final cementation of endocrown.

Conditions

Endodontically Treated Molar; Marginal Fit; Internal Fit

Keywords

Endocrown

Outcome Measures

Primary Outcomes (1)

• Marginal fit

  stereomicroscope by Micrometer

  2 weeks

Secondary Outcomes (1)

• Internal fit

  2 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Bevel marginal design endocrown for endodontically treated teeth

Other: Bevel marginal design endocrown for endodontically treated teeth

Control group

ACTIVE COMPARATOR

Butt marginal design endocrown for endodontically treated teeth

Other: Butt marginal design endocrown for endodontically treated teeth

Interventions

Bevel marginal design endocrown for endodontically treated teeth OTHER

Bevel marginal design will be prepared for endodontically treated teeth and restores with Peek endocrown

Intervention group

Butt marginal design endocrown for endodontically treated teeth OTHER

Butt marginal design will be prepared for endodontically treated teeth and restores with Peek endocrown

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient age range from 18 years -50 years old. They should be able to read and write so they can sign the informed consent.
• Patient should have a good physical and psychologically state to be able to withstand the steps of the restoration procedure.
• Have a molar with root canal filling with no active periodontal or apical involvement.
• Patients having root canal treatment teeth indicated for endocrown treatment with 3 or 4 axial walls remaining.
• Patient with axial wall length not less than 3 mm and not more than 5 mm.
• Patient should have good oral hygiene and motivation.

You may not qualify if:

• Patient with periodontal or apical involvement or improper root canal treatment.
• Severe loss of the tooth structure in which the amount of the remaining tooth structure is less than 2mm.
• Patient with poor oral hygiene or with occlusal instability
• Patient with improper physical or psychological state.
• Patient not pregnant or lactating.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

Study Officials

• Fatema K. Mansour

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatema K. Mansour, Assist Lect.

CONTACT

01142212367; fatemakhaledmansour@gmail.com

Fatema K. Mansour, Assist Lect.

CONTACT

01119755516; fmansour@msa.eun.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and recruiters will not know the study group to which the next participant will be assigned. The trial participants, outcome assessors, and data analysis will be blinded after assignment to interventions. Emergency un-blinding: In cases of emergency to decrease or prevent any harms for the participants.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: September 17, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)