NCT04922372

Surface Texture and Clinical Performance of Milled BioHPP Polyetheretherketone (PEEK) Single Posterior Crowns Veneered With Two Different Techniques

Status unknown Phase 4 Last updated 16 June 2021

What this trial tests

Phase 4 trial testing peek in Surface Roughness in 26 participants. Status unknown.

Timeline

22 July 2021

Primary endpoint
22 July 2022

22 December 2022

Quick facts

Lead sponsor	Cairo University
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	26
Start date	22 July 2021
Primary completion	22 July 2022
Estimated completion	22 December 2022

Drugs / interventions tested

• peek

Conditions studied

• Surface Roughness — all drugs for Surface Roughness →

Sponsor

Cairo University

Who can join

Adults 18 to 50, any sex, with Surface Roughness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Research question:

For patients requiring posterior single crowns, does the use of Milled BioHPP PEEK copings veneered with CAD/CAM composite resin offer better surface texture and clinical performance when compared Milled BioHPP PEEK copings veneered with manual layering?

Statement of the problem Nowadays, metal free restorations are widely used. PEEK is one among these restorations that has many applications in dental field. Owing to PEEK's excellent mechanical properties, it is gaining popularity in prosthodontics. The opaque nature of PEEK allows its use as a framework material in fixed prosthodontics and composite resin material is used as a veneering material to achieve aesthetics .

The compatible composite veneering material can be manufactured by both manual and CAD/CAM techniques. Yet, there is no enough research regarding the influence of the veneering technique on the surface texture and clinical performance of these restorations.

Rationale PEEK combination of mechanical properties and high biocompatibility make it a very promising material . PEEK based crowns are veneered by composite resin material. Among the methods of fabrication of veneering composite is the manual layering and CAD/CAM techniques . The surface flaws and internal defects determine the strength of the material and affects its performance . Accordingly the evaluation of the veneering technique is mandatory.

The rationale for carrying out this study lies in providing an alternative solution to the manual veneering technique, which will, in-turn, provide better surface properties and clinical performance of the restoration and accordingly increase its longevity.

Aim of the study:

\- The aim of this study is to evaluate the surface texture and clinical performance of milled BioHPP PEEK veneered with CAD/CAM composite resin and compare them to milled BioHPP PEEK veneered manually.

Null hypothesis:

There is no difference in the surface texture and clinical performance between milled BioHPP PEEK veneered with CAD/CAM composite resin and milled BioHPP PEEK veneered manually.

Primary objective:

* Primary outcome: (surface texture) of the two groups will be assessed using the modified USPHS.
* Secondary outcome: (fracture) of the two groups will be assessed using the modified Ryge criteria.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.