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

Assessment of Marginal and Internal Fit of High Performance Polymer Endocrown Using Two Preparation Designs (Randomized Clinical Trial)

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.

Study Overview

• Status: Recruiting
• Conditions: Endodontically Treated Molar; Marginal Fit; Internal Fit
• Intervention / Treatment: Other: Bevel marginal design endocrown for endodontically treated teeth; Other: Butt marginal design endocrown for endodontically treated teeth

Detailed Description

Examination and diagnosis:

Selection and examination of the patients according to inclusion and exclusion criteria. Diagnosis of the patient's chief complaint and teeth that will be involved in this study will be done.

Primary alginate impressions for diagnosis on primary casts and for mounting. The patients will be asked to maintain good oral hygiene measures by using tooth brush twice daily.

Taking a professional pre-operative photo.

Tooth preparation procedure:

Preparation of endocrown with two preparation designs on endodontically treated molars.

After tooth preparation, the final impression will be taken for each participant using polyvinyl siloxane impression and temporization of cavity using light curable temporary material.

Restoration trial appointment:

Endocrown try in and assessment of marginal and internal fit using replica technique with light body rubber impression.

Fabrication of final restoration:

Delivery of high performance polymer endocrown will be fabricated according to the two preparation designs; butt and bevel.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatema K. Mansour, Assist Lect.; Phone Number: 01142212367; Email: fatemakhaledmansour@gmail.com
• Study Contact Backup: Name: Fatema K. Mansour, Assist Lect.; Phone Number: 01119755516; Email: fmansour@msa.eun.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University
    • Contact: Fatema K. Mansour, Assis. Lect.; Phone Number: 01142212367; Email: fatemakhaledmansour@gmail.com
    • Contact: Aisha K. Mansour; Phone Number: 01119755516; Email: akmansour@msa.eun.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Bevel marginal design endocrown for endodontically treated teeth	Other: Bevel marginal design endocrown for endodontically treated teeth; Bevel marginal design will be prepared for endodontically treated teeth and restores with Peek endocrown
Active Comparator: Control group; Butt marginal design endocrown for endodontically treated teeth	Other: Butt marginal design endocrown for endodontically treated teeth; Butt marginal design will be prepared for endodontically treated teeth and restores with Peek endocrown

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal fit	stereomicroscope by Micrometer	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Internal fit	stereomicroscope by Micrometer	2 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Fatema K. Mansour, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): September 17, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Endocrown
• Other Study ID Numbers: 3324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No