Clinical Evaluation of Internal Fit of Milled BioHPP Polyetheretherketone (PEEK) - Based Versus Zirconia-Based Single Crowns

NCT ID: NCT04052789

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-08-01

Brief Summary

All ceramic crowns are indicated in case of mild to moderate discoloration, restoration of traumatized or fractured teeth and abnormal tooth anatomy. The success of dental restorations is determined by four main factors: biocompatibility, aesthetic value, resistance to fracture and marginal adaptation. . An inadequate marginal fit may compromise the longevity of the restoration since cement film exposure to the oral environment can lead to its dissolution . .

Polyetheretherketone (PEEK) is a polymer that has many potentials uses in dentistry. Polyetheretherketone (PEEK) can be used to support fixed dental prostheses. However, information about physio mechanical characterization is still scarce.

Aim of the study:

• The aim of this study is to evaluate the internal fit of milled BioHPP PEEK-based versus zirconia-based single crowns.

Conditions

Badly Decayed Teeth andTeeth Restored With Large Filling Restorations and Endodontically Treated Teeth and Malformed Teeth and Malposed Teeth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zirconia single posterior crowns veneered with ceramics

'In the first visit, a Face-to-Face adherence session will be held in which the patient should be informed about the study steps and how to maintain oral hygiene measures. Further sessions will occur at the follow-up visits

Group Type: ACTIVE_COMPARATOR

BioHPP PEEK copings veneered with composite resin

Intervention Type: OTHER

In the first visit, a Face-to-Face adherence session will be held in which the patient should be informed about the study steps and how to maintain oral hygiene measures. Further sessions will occur at the follow-up visits . Participant patients will be asked about any problems they are having. Patients will be recalled every two months for one year for follow up visits.

BioHpp PEEK single posterior crowns veneered with compos

In the first visit, a Face-to-Face adherence session will be held in which the patient should be informed about the study steps and how to maintain oral hygiene measures. Further sessions will occur at the follow-up visits

Group Type: EXPERIMENTAL

BioHPP PEEK copings veneered with composite resin

Intervention Type: OTHER

In the first visit, a Face-to-Face adherence session will be held in which the patient should be informed about the study steps and how to maintain oral hygiene measures. Further sessions will occur at the follow-up visits . Participant patients will be asked about any problems they are having. Patients will be recalled every two months for one year for follow up visits.

Interventions

BioHPP PEEK copings veneered with composite resin

In the first visit, a Face-to-Face adherence session will be held in which the patient should be informed about the study steps and how to maintain oral hygiene measures. Further sessions will occur at the follow-up visits . Participant patients will be asked about any problems they are having. Patients will be recalled every two months for one year for follow up visits.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• From 18-50 years old, be able to read and sign the informed consent document.
• Patient Have no active periodontal or pulpal diseases, have teeth with good restorations
• Patient Psychologically and physically able to withstand conventional dental procedures
• Patients with teeth problems indicated for single posterior crowns:

Exclusion Criteria

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

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nahla Gamal Adly

Resident, Fixed Prosthodontices Department,Faculty of Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Nahla Adly, M.D.S

Role: CONTACT

Dr.nahla.81@gmail.com

01010604355

Amina Zaki, professor

Role: CONTACT

aazaki99@yahoo.co.uk

Other Identifiers

CEBD-CU-2019-08-03

Identifier Type: -

Identifier Source: org_study_id