One Year Clinical Evaluation of Milled BioHPP Polyetheretherketone (PEEK)-Based Versus Metal Ceramic Single Crowns

Single Posterior Crowns Clinical Trial

Official title:

One Year Clinical Evaluation of Milled BioHPP Polyetheretherketone (PEEK)-Based Versus Metal Ceramic Single Crowns

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03685513
• Other study ID #: CEBD-CU-2018-09-30
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: September 2018
• Source: Cairo University
• Contact: Abdelrahman Badran, M.D.s
• Phone: 01007029340
• Email: asbadran77[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although the metal-ceramic system is still widely used to fabricate crowns and fixed partial dentures and is considered as the standard treatment in dentistry, aesthetic concerns have stimulated the development of new dental tooth-colored systems as PEEK.

BioHPP PEEK is 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymer for extreme durability especially for frameworks for fixed and removable dental prostheses. It has many advantages as low density, light weight, shock absorber, biocompatible and venerable with composite resin.

The aim of this study is to evaluate the clinical performance of milled BioHPP PEEK-based single crowns and compare them to metal-based single crowns.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: June 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• 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

Related Conditions & MeSH terms

• Badly Decayed Teeth, Teeth Restored With Large Filling Restorations or Endodontically Treated Teeth
• Dental Caries
• Malformed Teeth, Malposed Teeth (Tilted, Over-erupted, Rotated, Etc.) or Spacing Between Posterior Teeth
• Single Posterior Crowns
• Tooth Abnormalities
• Tooth, Nonvital

Intervention

Other:
• BioHPP PEEK-based single posterior crowns
BioHPP PEEK is 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymer for extreme durability especially for frameworks for fixed and removable dental prostheses. It has many advantages as low density, light weight, shock absorber, biocompatible and venerable with composite resin.
• Metal ceramic single posterior crowns
Standard metal coping veneered with glass ceramics

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	Measured using modified USPHS criteria	1 year
Primary	Fracture	Measured using modified USPHS criteria	1 year
Secondary	Marginal adaptation	Measured using modified USPHS criteria	1 year