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 Clinical Trial

Official title:
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 )

Status Not yet recruiting

Clinical Trial 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Performance

Clinical Trial Details

NCT number	NCT06092697
Study type	Interventional
Source	Cairo University
Contact
Status	Not yet recruiting
Phase	N/A
Start date	October 2023
Completion date	April 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03599232` - Impact of Formative OSCE on Students' Summative Clinical Performance	N/A
Not yet recruiting	`NCT05928533` - Performance Of Cervical Restorations Using Nitric Acid and Mineral Enriched Adhesive Versus Phosphoric Acid and Universal Adhesive	N/A
Not yet recruiting	`NCT03697005` - One Year Clinical Evaluation of Pressed BioHPP Polyether Ether Ketone (PEEK)-Based Versus Zirconia-Based Single Crowns	N/A
Completed	`NCT03375073` - Positive Communication and Clinical Performance in Anaesthetic Care.	N/A
Terminated	`NCT01992120` - Utility of High-Fidelity Simulation In the Education and Assessment of Residents in the Recognition and Management of the Sepsis Syndrome	N/A
Completed	`NCT04284527` - The Assessment of Physiotherapy Practice Validation as a Measure in Physiotherapy Student
Not yet recruiting	`NCT05509127` - Evaluation of Cervical Restorations Performance Using Modified Universal Adhesive	Phase 1
Recruiting	`NCT04396080` - Prospective Clinical Trial of Onlay-carrying Patients	N/A
Not yet recruiting	`NCT05945758` - Esthetic and Clinical Assessment of Injectable Resin Composite Technique	N/A
Completed	`NCT05334901` - Performance of Curing Times and Intensitis	N/A
Not yet recruiting	`NCT05808075` - Clinical Performance of Nano Fiber Reinforced Versus Conventional Nano Hybrid Composite in Restoring Premolars	N/A
Recruiting	`NCT05337358` - Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns Versus Conventional Lithium Disilicate Endocrowns in Posterior Teeth (1y Randomized Clinical Trial).	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.