Evaluation of 3D Printed Polyether Ether Ketone (PEEK) and Milled PEEK Indirect Restorations Compared to Hybird Resin Composite Indirect Restorations Over One Year Period of Time ( A Randomized Clinical Trial )

NCT06092697 | Unknown

• 1 other identifier: Hadeer'sPROTOCOL-PHD
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical performance evaluation of 3D Printed Polyether ether ketone (PEEK) and milled PEEK indirect restorations compared to hybird resin composite indirect restorations over one year period of time

Conditions

Clinical Performance

Outcome Measures

Primary Outcomes (1)

• Fracture and retention (Category F1)(Revised FDI criteria for evaluating direct and indirect dental restorations- recommendations for its clinical use, interpretation, and reporting)

  Outcome:Fracture of the material and retention Measuring device: Revised FDI criteria for evaluating direct and indirect dental restorations- recommendations for its clinical use, interpretation, and reporting. (Hickel et al., 2023) Measuring unit: Scoring system (Ordinal) 1. Clinically excellent/very good (sufficient) 2. Clinically good (sufficient) 3. Clinically satisfactory (sufficient) 4. Clinically unsatisfactory (partially insufficient) 5. Clinically poor (entirely insufficient)

  Baseline, 6 months, 12 months

Secondary Outcomes (1)

• occlusion and wear (Category F5)

  Baseline, 6 months, 12 months

Study Arms (3)

3D printed PEEK

EXPERIMENTAL

Indirect dental restoration

Other: 3D printed PEEK restorations

Milled PEEK

EXPERIMENTAL

Indirect dental restoration

Other: 3D printed PEEK restorations

Hybird resin composite

ACTIVE COMPARATOR

Indirect dental restoration

Other: 3D printed PEEK restorations

Interventions

3D printed PEEK restorations OTHER

Indirect dental restoration

Also known as: Milled PEEK

3D printed PEEK; Hybird resin composite; Milled PEEK

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aging (18-45) years.
• Patients with a high level of oral hygiene.
• Each patient enrolled in the study should have moderate carious lesion or defective restoration needs to be replaced on a mandibular permanent molar.
• Patients with ability to attend periodical follow-ups.

You may not qualify if:

• Patients with general/systemic diseases or allergies.
• Patients with chronic use of anti- inflammatory, analgesic, and psychotropic drugs.
• Pregnant or lactating females.
• Patients with parafunctional habits.
• Patients with experience of allergic reactions against any components of the used materials.
• Patients receiving orthodontic treatment.
• Inability to comply with study procedures.
• Collateral participation in another research study.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• Abhay SS, Ganapathy D, Veeraiyan DN, Ariga P, Heboyan A, Amornvit P, Rokaya D, Srimaneepong V. Wear Resistance, Color Stability and Displacement Resistance of Milled PEEK Crowns Compared to Zirconia Crowns under Stimulated Chewing and High-Performance Aging. Polymers (Basel). 2021 Oct 30;13(21):3761. doi: 10.3390/polym13213761.

  PMID: 34771318 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Assistant at MSA UNIVERSITY

Model Details: A superiority frame randomized, controlled, parallel clinical trial with 1:1 allocation ratio.

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 23, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: April 1, 2025
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share