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 )

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

Study Overview

• Status: Not yet recruiting
• Conditions: Clinical Performance
• Intervention / Treatment: Other: 3D printed PEEK restorations

Detailed Description

The aim of this study is to evaluate fracture and retention, wear of 3D printed PEEK indirect restorations and milled PEEK indirect restorations compared to milled indirect hybrid resin composite restorations according to FDI criteria over one year.

According to indirect restorations cavity preparation principles, shade selection and occlusal examination will be done preoperatively, followed by cavity preparations that will be carried out with tapered diamond stones.

The prepared teeth for the indirect restorations will be scanned with an optical scanner. Then restorations will be designed by a CAD software and files will be made in STL format, so as to be ready for either 3D printing or milling with different materials.

While the printed PEEK restorations are additively made, the milled PEEK and hybrid composite restorations are both milled out of either a disc or block ( size 12) using a CAD/CAM milling machine.

After the printing and the milling procedures are complete, the restorations are then promptly removed. Each restoration will be assessed and adjusted for its cavity after the occlusal surface is recontoured. This post-processing adjustments will be applied to both 3d printed ones and milled restorations. After assessment and needed adjustments are done, all restorations will be cemented into the cavities in accordance with the manufacturer's recommendations.

For each recall examination, two independent evaluators will perform the direct clinical evaluation for the fracture and retention at baseline, after 6 and 12 months using written criteria based on FDI world dental federation criteria. Together with the wear testing that will be performed by scanning of the restoration surfaces at baseline, after 6 and 12 months. Using parallel confocal technology, a 3D dental scanner (CEREC Primescan; Sirona, Bensheim, Germany) to attain the 3D Standard Tessellation Language (STL) models will be used. These scan models will be then introduced through a wear measuring software (Geomagic Design X; 3D Systems, Seoul, Korea) which will import, analyze, and superimpose the digitalized 3D models. So, it will automatically calculate the amount of occlusal volume lose due to wear.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D printed PEEK; Indirect dental restoration	Other: 3D printed PEEK restorations; Indirect dental restoration; Other Names: Milled PEEK
Experimental: Milled PEEK; Indirect dental restoration	Other: 3D printed PEEK restorations; Indirect dental restoration; Other Names: Milled PEEK
Active Comparator: Hybird resin composite; Indirect dental restoration	Other: 3D printed PEEK restorations; Indirect dental restoration; Other Names: Milled PEEK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
occlusion and wear (Category F5)	Wear potential of the restoration Measuring device: A. Digital scanner (CEREC Primescan intraoral Scanner) B. Geometrical Subtraction software (Geomagic control software) (Tang et al. 2021) Measuring unit : Microns (Quantitative)	Baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 15, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 15, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Hadeer'sPROTOCOL-PHD

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