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

Patient Satisfaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03697005
• Other study ID #: CEBD-CU-2018-09-40
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: October 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Clinical Performance
• Patient Satisfaction

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	patient satisfaction	patient satisfaction assessed by VAS questionnaire	one year
Primary	Fracture	Fracture of the single crowns assessed by modified Ryge criteria (Alpha, Bravo, Charlie and Delta)	one year
Secondary	Marginal adaptation	Marginal adaptation assessed by modified Ryge criteria (Alpha, Bravo, Charlie and Delt	one year