One Year Clinical Evaluation of Pressed BioHPP Polyether Ether Ketone (PEEK)-Based Versus Zirconia-Based Single Crowns

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03697005

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The clinical performance (using the modified Ryge criteria) and patient satisfaction ( using VAS questionnaire) of pressed BioHPP PEEK based posterior single crowns compared to zirconia based crowns are questionable as the peek is considered as a new material and need to be tested for future clinical application.

Condition or Disease	Intervention/Treatment	Phase
Clinical Performance Patient Satisfaction	Other: BioHPP PEEK single posterior crowns Other: zirconia-based single posterior crowns	N/A

Detailed Description

The study is held to evaluate the clinical performance (using the modified Ryge criteria) and patient satisfaction ( using VAS questionnaire) of pressed BioHPP PEEK based posterior single crowns compared to zirconia based crowns after one year follow-up. Patients requiring posterior single crowns are collected. After teeth preparation to receive single full coverage crowns, secondary impressions were taken. The patients were divided randomly into two groups ;one group will receive pressed BioHPP PEEK single crowns (the intervention) and the other group will receive veneered zirconia single crowns (the control). Fracture of restorations (1ry outcome) using modified Ryge criteria and the marginal adaptation (2ry outcome) using modified Ryge criteria and finally the patient satisfaction (3ry outcome) using a questionnaire, all outcomes will be evaluated every 2 months with total period of follow-up of one year.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

patients requiring posterior single crowns.patients requiring posterior single crowns.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Double blinding (trial participants and outcome assessor) Dental colleague assessors who are blinded about the aim of the study and participant's allocation will be responsible for assessing the outcomes of this study. The level of intra- and inter-examiner reliability will be determined for each assessor by the performance of a calibration session prior to the start of the trial. A training exercise to the assessors with the main investigator will help to standardize measurement techniques and parameters. An interactive calibration session will enable the investigator to quantitate the measurement variability among and between assessors and enable the optimization of the measurement process. The main supervisor will solve any conflict that may arise between the assessors by repeating the assessing and giving the final opinion.

Primary Purpose:

Treatment

Official Title:

One Year Clinical Evaluation of Pressed BioHPP Polyether Ether Ketone (PEEK)-Based Versus Zirconia-Based Single Crowns (Randomized Controlled Clinical Trial)

Anticipated Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Nov 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BioHPP PEEK single posterior crowns BioHPP PEEK copings veneered with composite resin	Other: BioHPP PEEK single posterior crowns BioHPP is a 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymeric material, used for fabrication of high strength fixed and removable prostheses. it has advantages of bio-compatibility, low density, light weight, shock absorption. Other Names: BioHPP PEEk copings veneered with composite resin
Active Comparator: zirconia-based single posterior crowns yttria stabilized tetragonal zirconia used as copings to be veneered with porcelain	Other: zirconia-based single posterior crowns ZrO2, a ceramic material used for medical devices, displays good esthetic appearance, high mechanical strength, and high biocompatibility and is used in a wide range of indications, such as frameworks, implants, and abutments. In addition, it's very good long-term stability and reliability was proven in a 10-year clinical study. These excellent material properties and the transformation behavior are explained by the yttrium oxide stabilization of ZrO2. Other Names: zirconia copings veneered with porcelain

Arm

Intervention/Treatment

Experimental: BioHPP PEEK single posterior crowns

BioHPP PEEK copings veneered with composite resin

Other: BioHPP PEEK single posterior crowns

BioHPP is a 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymeric material, used for fabrication of high strength fixed and removable prostheses. it has advantages of bio-compatibility, low density, light weight, shock absorption.

Other Names:

BioHPP PEEk copings veneered with composite resin

Active Comparator: zirconia-based single posterior crowns

yttria stabilized tetragonal zirconia used as copings to be veneered with porcelain

Other: zirconia-based single posterior crowns

ZrO2, a ceramic material used for medical devices, displays good esthetic appearance, high mechanical strength, and high biocompatibility and is used in a wide range of indications, such as frameworks, implants, and abutments. In addition, it's very good long-term stability and reliability was proven in a 10-year clinical study. These excellent material properties and the transformation behavior are explained by the yttrium oxide stabilization of ZrO2.

Other Names:

zirconia copings veneered with porcelain

Outcome Measures

Primary Outcome Measures

Fracture [one year]
Fracture of the single crowns assessed by modified Ryge criteria (Alpha, Bravo, Charlie and Delta)

Secondary Outcome Measures

Marginal adaptation [one year]
Marginal adaptation assessed by modified Ryge criteria (Alpha, Bravo, Charlie and Delt

Other Outcome Measures

patient satisfaction [one year]
patient satisfaction assessed by VAS questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 with teeth problems indicated for single posterior crowns:
Badly decayed teeth
Teeth restored with large filling restorations
Endodontically treated teeth
Malformed teeth
Malposed teeth (Tilted, over-erupted, rotated, etc.)
Spacing between posterior teeth
Able to return for follow-up examinations and evaluation

Exclusion Criteria:

Patient less than 18 or more than 50 years
Patient with active resistant periodontal diseases
Patients with poor oral hygiene and uncooperative patients
Pregnant women
Patients in the growth stage with partially erupted teeth
Psychiatric problems or unrealistic expectations
Lack of opposing dentition in the area of interest
Failed endodotically treated teeth; short or overextended, narrow, missed canal, ledge or perforated teeth (even if no clear symptoms for failure)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aya Ezzat Mohamed Ali El-shimy, Assistant lecturer, fixed prosthodontic department, faculty of dentistry, Cairo University

ClinicalTrials.gov Identifier:

NCT03697005

Other Study ID Numbers:

CEBD-CU-2018-09-40

First Posted:

Oct 5, 2018

Last Update Posted:

Oct 5, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 5, 2018