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

NCT ID: NCT03685513

Last Updated: 2018-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Double blind

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Metal ceramic single posterior crowns

Metal copings veneered with feldspathic porcelain

Group Type ACTIVE_COMPARATOR

Metal ceramic single posterior crowns

Intervention Type OTHER

Standard metal coping veneered with glass ceramics

BioHPP PEEK-based single posterior crowns

BioHPP PEEK copings veneered with composite resin

Group Type EXPERIMENTAL

BioHPP PEEK-based single posterior crowns

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Metal ceramic single posterior crowns

Standard metal coping veneered with glass ceramics

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Porcelain fused to metal (PFM) or Ceramo-metallic

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Abdelrahman Soliman Elsayed Badran

Resident, Fixed Prosthodontics Department, Faculty of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Abdelrahman Badran, M.D.s

Role: CONTACT

01007029340

Amina Zaki

Role: CONTACT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CEBD-CU-2018-09-30

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.