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

NCT03685513 | Unknown

• 1 other identifier: CEBD-CU-2018-09-30
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Fracture

  Measured using modified USPHS criteria

  1 year

Secondary Outcomes (1)

• Marginal adaptation

  1 year

Other Outcomes (1)

• Patient Satisfaction

  1 year

Study Arms (2)

Metal ceramic single posterior crowns

ACTIVE COMPARATOR

Metal copings veneered with feldspathic porcelain

Other: Metal ceramic single posterior crowns

BioHPP PEEK-based single posterior crowns

EXPERIMENTAL

BioHPP PEEK copings veneered with composite resin

Other: BioHPP PEEK-based single posterior crowns

Interventions

BioHPP PEEK-based single posterior crowns 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.

BioHPP PEEK-based single posterior crowns

Metal ceramic single posterior crowns OTHER

Standard metal coping veneered with glass ceramics

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

Metal ceramic single posterior crowns

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• From 18-50 years old, be able to read and sign the informed consent document.
• Have no active periodontal or pulpal diseases, have teeth with good restorations
• Psychologically and physically able to withstand conventional dental procedures
• Patients with teeth problems indicated for single posterior crowns:
• Badly decayed teeth
• Teeth restored with large filling restorations
• Endodontically treated teeth
• Malformed teeth
• Malposed teeth (Tilted, over-erupted, rotated, etc.)
• Spacing between posterior teeth
• Able to return for follow-up examinations and evaluation

You may not qualify if:

• Patient less than 18 or more than 50 years
• Patient with active resistant periodontal diseases
• Patients with poor oral hygiene and uncooperative patients
• Pregnant women
• Patients in the growth stage with partially erupted teeth
• Psychiatric problems or unrealistic expectations
• Lack of opposing dentition in the area of interest

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Tooth, Nonvital; Tooth Abnormalities

Interventions

Melanocyte-Stimulating Hormones

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Central Study Contacts

Abdelrahman Badran, M.D.s

CONTACT

01007029340; asbadran77@gmail.com

Amina Zaki

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Fixed Prosthodontics Department, Faculty of Dentistry

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 26, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: June 1, 2020
• Last Updated: September 26, 2018

Record last verified: 2018-09