Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns

NCT06348979 | Completed DMC

• 1 other identifier: CEBD 5/2021
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This research proposal is introduced to clinically test short fiber reinforced flowable resin composite material (everX Flow, GC Europe) as a supporting base under CAD/CAM resin composite endocrowns due to gap of knowledge present in this area.

Conditions

Dental Caries

Keywords

restoration fracture; CAD/CAM resin composite endocrowns; lithium disilicate endocrowns

Outcome Measures

Primary Outcomes (1)

• clinical Fracture

  modified usphs criteria (alpha, bravo, charlie) with measuring unit: scoring system (ordinal)

  change from baseline and months: 3, 6, 12

Secondary Outcomes (1)

• clinical performance marginal adaptation

  change from baseline and months: 3, 6, 12

Study Arms (2)

Hybrid Nano-ceramic (Grandio) CAD/CAM Endocrowns

EXPERIMENTAL

Adding of short fiber reinforced flowable resin composite material (everX Flow, GC Europe) as a supporting base under CAD/CAM resin composite endocrowns

Procedure: Fiber flowable (SFRC) support below hybrid nanoceramic endocrowns

Lithium Disilicate (e.max) Endocrowns

ACTIVE COMPARATOR

Lithium Disilicate (e.max) Endocrowns

Procedure: all ceramic Endocrowns (emax)

Interventions

Fiber flowable (SFRC) support below hybrid nanoceramic endocrowns PROCEDURE

restoration of endodontically treated teeth by endocrowns

Also known as: Grandio CAD/CAM block

Hybrid Nano-ceramic (Grandio) CAD/CAM Endocrowns

all ceramic Endocrowns (emax) PROCEDURE

restoration of endodontically treated teeth by endocrowns

Lithium Disilicate (e.max) Endocrowns

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Endodontically treated molar teeth indicated for endocrown.
• Presence of favorable occlusion and teeth are in normal alignment with the adjacent teeth, -medically free

You may not qualify if:

• ▪ Endodontically treated molar teeth indicated for post and core or only crown coverage.
• Severe periodontal problems

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

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, Conservative dentistry department, Faculty of Dentistry, Cairo University.

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: April 5, 2024
• Study Start: January 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: January 30, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)