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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04052789
Collaborator
(none)
16
Enrollment
2
Arms
11
Anticipated Duration (Months)

Study Details

Study Description

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.
Condition or Disease Intervention/Treatment Phase
  • Other: BioHPP PEEK copings veneered with composite resin
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
Double(participant, outcome Assessor) Double blind
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of Internal Fit of Milled BioHPP Polyetheretherketone (PEEK) - Based Versus Zirconia-Based Single Crowns
Anticipated Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Aug 1, 2020
Anticipated Study Completion Date :
Aug 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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

Other: 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.
Experimental: 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

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Internal fit of the crown by measuring the thickness of the replica by steriomicroscope [one year]

    measured by replica technique and steriomicroscope

Secondary Outcome Measures

  1. secondary caries if present at the margin of the crown by using probe [one year]

    Measured by modified Ryge criteria Alpha (A)The restoration is a continuation of existing anatomic form adjacent to the restoration. Bravo (B)There is visual evidence of dark keep discoloration adjacent to the restoration (but notAlpha (A)The restoration is a continuation of existing anatomic form adjacent to the restoration. Bravo (B)There is visual evidence of dark keep discoloration adjacent to the restoration (but not directly associated with cavosurface margins). directly associated with cavosurface margins).

Other Outcome Measures

  1. patient satisfaction [one year]

    Measured by VAS(questionnaire)Numerical (discrete) ("0" unsatisfied - "10" satisfied)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nahla Gamal Adly, Resident, Fixed Prosthodontices Department,Faculty of Dentistry, Cairo University
ClinicalTrials.gov Identifier:
NCT04052789
Other Study ID Numbers:
  • CEBD-CU-2019-08-03
First Posted:
Aug 12, 2019
Last Update Posted:
Aug 13, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Tooth, Nonvital
Dental Caries

Study Results

No Results Posted as of Aug 13, 2019