Clinical trial NCT03697005: One Year Clinical Evaluation of Pressed BioHPP Polyether Ether Ketone (PEEK)-Based Versus Zirconia-Based Single Crowns
Official title: One Year Clinical Evaluation of Pressed BioHPP Polyether Ether Ketone (PEEK)-Based Versus Zirconia-Based Single Crowns (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clinical Performance
Patient Satisfaction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients requiring posterior single crowns.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Fracture
timeFrame: one year
Secondary outcomes:
measure: Marginal adaptation
timeFrame: one year
Other outcomes:
measure: patient satisfaction
timeFrame: one year
Locations:
Study officials:
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