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

• ClinicalTrials.gov Identifier: NCT04052789
• Recruitment Status: Unknown
• First Posted: August 12, 2019
• Last Update Posted: August 13, 2019
• Sponsor: Cairo University
• Information provided by (Responsible Party): Nahla Gamal Adly, Cairo University

Tracking Information

• First Submitted Date: August 4, 2019
• First Posted Date: August 12, 2019
• Last Update Posted Date: August 13, 2019
• Estimated Study Start Date: September 1, 2019
• Estimated Primary Completion Date: August 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 9, 2019)

Internal fit of the crown by measuring the thickness of the replica by steriomicroscope [ Time Frame: one year ]

measured by replica technique and steriomicroscope

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 9, 2019)

secondary caries if present at the margin of the crown by using probe [ Time Frame: 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).

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: August 9, 2019)

patient satisfaction [ Time Frame: one year ]

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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Clinical Evaluation of Internal Fit of Milled BioHPP Polyetheretherketone (PEEK) - Based Versus Zirconia-Based Single Crowns
• Official Title: Clinical Evaluation of Internal Fit of Milled BioHPP Polyetheretherketone (PEEK) - Based Versus Zirconia-Based Single Crowns

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:

Double(participant, outcome Assessor) Double blind

Primary Purpose: Treatment

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

Intervention

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.

Study Arms

• 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
  Intervention: Other: BioHPP PEEK copings veneered with composite resin
• 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
  Intervention: Other: BioHPP PEEK copings veneered with composite resin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 9, 2019): 16
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 1, 2020
• Estimated Primary Completion Date: August 1, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04052789
• Other Study ID Numbers: CEBD-CU-2019-08-03
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Nahla Gamal Adly, Cairo University
• Original Responsible Party: Same as current
• Current Study Sponsor: Cairo University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Cairo University
• Verification Date: August 2019