CClinicalTrials.gg
Status unknownNCT03685513Updated Sep 26, 2018

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

An interventional study of BioHPP PEEK-based single posterior crowns and Metal ceramic single posterior crowns in Single Posterior Crowns, Badly Decayed Teeth, Teeth Restored With Large Filling Restorations or Endodontically Treated Teeth and Malformed Teeth, Malposed Teeth (Tilted, Over-erupted, Rotated, Etc.) or Spacing Between Posterior Teeth, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-09-26.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Single Posterior Crowns
  • Badly Decayed Teeth, Teeth Restored With Large Filling Restorations or Endodontically Treated Teeth
  • Malformed Teeth, Malposed Teeth (Tilted, Over-erupted, Rotated, Etc.) or Spacing Between Posterior Teeth
03

In context

Tooth, Nonvital

113 studies on the registry are indexed under Tooth, Nonvital; 19 are open to participants now.

This study's planned enrollment of 46 is close to the median of 50 across 103 interventional studies indexed under Tooth, Nonvital.

Browse Tooth, Nonvital studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
46 participants (estimated)

Study arms

  • Active comparator
    Metal ceramic single posterior crowns

    Metal copings veneered with feldspathic porcelain

    Other: Metal ceramic single posterior crowns

  • Experimental
    BioHPP PEEK-based single posterior crowns

    BioHPP PEEK copings veneered with composite resin

    Other: BioHPP PEEK-based single posterior crowns

Interventions

  • OtherBioHPP 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.

  • OtherMetal ceramic single posterior crowns

    Standard metal coping veneered with glass ceramics

    Also known as: Porcelain fused to metal (PFM) or Ceramo-metallic

06

What researchers measure

Primary outcomes

  1. Fracture

    Measured using modified USPHS criteria

    Time frame: 1 year

Secondary outcomes

  1. Marginal adaptation

    Measured using modified USPHS criteria

    Time frame: 1 year

Other outcomes

  1. Patient Satisfaction

    Measured using modified USPHS criteria

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03685513
Lead sponsor
Cairo University
Responsible party
Abdelrahman Soliman Elsayed Badran (Resident, Fixed Prosthodontics Department, Faculty of Dentistry, Cairo University) — Principal investigator
First posted
Sep 26, 2018
Start date
Jan 1, 2019 (estimated)
Primary completion
Jan 1, 2020 (estimated)
Completion
Jun 1, 2020 (estimated)
Last update
Sep 26, 2018

Study contacts

Abdelrahman Badran, M.D.s
Contact
asbadran77@gmail.com
01007029340
Amina Zaki
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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