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

NCT03697005 | Unknown

• 1 other identifier: CEBD-CU-2018-09-40
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Clinical Performance; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• Fracture

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

  one year

Secondary Outcomes (1)

• Marginal adaptation

  one year

Other Outcomes (1)

• patient satisfaction

  one year

Study Arms (2)

BioHPP PEEK single posterior crowns

EXPERIMENTAL

BioHPP PEEK copings veneered with composite resin

Other: BioHPP PEEK single posterior crowns

zirconia-based single posterior crowns

ACTIVE COMPARATOR

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

Other: zirconia-based single posterior crowns

Interventions

BioHPP PEEK single posterior crowns 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.

Also known as: BioHPP PEEk copings veneered with composite resin

BioHPP PEEK single posterior crowns

zirconia-based single posterior crowns 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.

Also known as: zirconia copings veneered with porcelain

zirconia-based single posterior crowns

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Composite Resins; Dental Porcelain

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Resins, Synthetic; Plastics; Polymers; Macromolecular Substances; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Ceramics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer, fixed prosthodontic department, faculty of dentistry

Model Details: patients requiring posterior single crowns.

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 5, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: October 5, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share