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

NCT04922372 | Unknown Phase 4

• 1 other identifier: 261020
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Surface Roughness

Outcome Measures

Primary Outcomes (1)

• surface texture

  Alpha: Surface is smooth as the surrounding, Bravo: Surface is rough than the surrounding, Charlie: Surface is very rough avoiding movement of the explorer, Delta: New restoration is needed.

  one year

Secondary Outcomes (1)

• fracture

  one year

Study Arms (2)

intervention arm copping veneered with composite resin

EXPERIMENTAL

Combination Product: peek

control arm copping veneered with manual layering

ACTIVE COMPARATOR

Combination Product: peek

Interventions

peek COMBINATION_PRODUCT

After tooth preparation, adequate 2ry Impression using non aqueous elastomeric impression materials and bite registration will be taken. 5. Fabrication of the temporary restoration using composite resin temporary material and cemented using non Eugenol Zinc Oxide temporary cement. 11.a.iii. Fabrication and cementation of restoration: Bio-HPP will be supplied in the form of discs to fabricate crown core by CAD/CAM technology then veneered with two veneering techniques; the CAD/ CAM and the manual technique using the visio.lign system of appropriate shade. The finished Bio HPP crown will be cemented by adhesive resin cement according to manufacturer instruction

control arm copping veneered with manual layering; intervention arm copping veneered with composite resin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All subjects are required to be:
• From 18-50 years old, be able to read and sign the informed consent document.
• Have no active periodontal or pulpal diseases, have teeth with good restorations.
• Psychologically and physically able to withstand conventional dental procedures.
• Patients in a need for posterior crown.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

polyetheretherketone

Central Study Contacts

ahmed kamal ibrahim

CONTACT

00201000051061; ahmed.kamal@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 5, 2021
• First Posted: June 10, 2021
• Study Start: July 22, 2021
• Primary Completion: July 22, 2022
• Study Completion: December 22, 2022
• Last Updated: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share