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

NCT ID: NCT03697005

Last Updated: 2018-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-11-01

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.

Conditions

Clinical Performance; Patient Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BioHPP PEEK single posterior crowns

BioHPP PEEK copings veneered with composite resin

Group Type: EXPERIMENTAL

BioHPP PEEK single posterior crowns

Intervention Type: OTHER

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.

zirconia-based single posterior crowns

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

Group Type: ACTIVE_COMPARATOR

zirconia-based single posterior crowns

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

BioHPP PEEk copings veneered with composite resin; zirconia copings veneered with porcelain

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Aya Ezzat Mohamed Ali El-shimy

Assistant lecturer, fixed prosthodontic department, faculty of dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CEBD-CU-2018-09-40

Identifier Type: -

Identifier Source: org_study_id