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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Aya Ezzat Mohamed Ali El-shimy，Cairo University

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

October 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Fracture[ Time Frame: one year ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: patients requiring posterior single crowns.
Masking: Interventional
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

Condition ^ICMJE

Intervention ^ICMJE

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: 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.

Study Arms

Experimental: BioHPP PEEK single posterior crowns
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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

November 1, 2019

Estimated Primary Completion Date

October 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: 1. From 18-50 years old, be able to read and sign the informed consent document. 2. Have no active periodontal or pulpal diseases, have teeth with good restorations 3. Psychologically and physically able to withstand conventional dental procedures 4. Patients with teeth problems indicated for single posterior crowns: 1. Badly decayed teeth 2. Teeth restored with large filling restorations 3. Endodontically treated teeth 4. Malformed teeth 5. Malposed teeth (Tilted, over-erupted, rotated, etc.) 6. Spacing between posterior teeth 5. Able to return for follow-up examinations and evaluation Exclusion Criteria: 1. Patient less than 18 or more than 50 years 2. Patient with active resistant periodontal diseases 3. Patients with poor oral hygiene and uncooperative patients 4. Pregnant women 5. Patients in the growth stage with partially erupted teeth 6. Psychiatric problems or unrealistic expectations 7. Lack of opposing dentition in the area of interest 8. Failed endodotically treated teeth; short or overextended, narrow, missed canal, ledge or perforated teeth (even if no clear symptoms for failure)

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Aya Ezzat Mohamed Ali El-shimy，Cairo University

Study Sponsor ^ICMJE

Cairo University

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Cairo University

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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