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

Not Applicable

• Conditions: Clinical Performance; Patient Satisfaction
• Interventions: Other: zirconia-based single posterior crowns; Other: BioHPP PEEK single posterior crowns

• Registration Number: NCT03697005
• Lead Sponsor: Cairo University

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 Timeline

• Study First Submitted: 2018-09-28
• Status Verified: 2018-10
• Study Start: 2018-10-01
• Study First Submitted QC: 2018-10-03
• Last Update Submitted: 2018-10-03
• Study First Posted: 2018-10-05
• Last Update Posted: 2018-10-05
• Primary Completion: 2019-10-01
• Study Completion: 2019-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
zirconia-based single posterior crowns	zirconia-based single posterior crowns	yttria stabilized tetragonal zirconia used as copings to be veneered with porcelain
BioHPP PEEK single posterior crowns	BioHPP PEEK single posterior crowns	BioHPP PEEK copings veneered with composite resin

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Marginal adaptation	one year	Marginal adaptation assessed by modified Ryge criteria (Alpha, Bravo, Charlie and Delt