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Trial record 12 of 119 for:    ZIRCONIUM

One Year Clinical Evaluation of Pressed BioHPP Polyether Ether Ketone (PEEK)-Based Versus Zirconia-Based Single Crowns

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ClinicalTrials.gov Identifier: NCT03697005
Recruitment Status : Not yet recruiting
First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Aya Ezzat Mohamed Ali El-shimy, Cairo University

Brief Summary:
The clinical performance (using the modified Ryge criteria) and patient satisfaction ( using VAS questionnaire) of pressed BioHPP PEEK based posterior single crowns compared to zirconia based crowns are questionable as the peek is considered as a new material and need to be tested for future clinical application.

Condition or disease Intervention/treatment Phase
Clinical Performance Patient Satisfaction Other: BioHPP PEEK single posterior crowns Other: zirconia-based single posterior crowns Not Applicable

Detailed Description:
The study is held to evaluate the clinical performance (using the modified Ryge criteria) and patient satisfaction ( using VAS questionnaire) of pressed BioHPP PEEK based posterior single crowns compared to zirconia based crowns after one year follow-up. Patients requiring posterior single crowns are collected. After teeth preparation to receive single full coverage crowns, secondary impressions were taken. The patients were divided randomly into two groups ;one group will receive pressed BioHPP PEEK single crowns (the intervention) and the other group will receive veneered zirconia single crowns (the control). Fracture of restorations (1ry outcome) using modified Ryge criteria and the marginal adaptation (2ry outcome) using modified Ryge criteria and finally the patient satisfaction (3ry outcome) using a questionnaire, all outcomes will be evaluated every 2 months with total period of follow-up of one year.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: patients requiring posterior single crowns.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Double blinding (trial participants and outcome assessor)

  • Dental colleague assessors who are blinded about the aim of the study and participant's allocation will be responsible for assessing the outcomes of this study.
  • The level of intra- and inter-examiner reliability will be determined for each assessor by the performance of a calibration session prior to the start of the trial. A training exercise to the assessors with the main investigator will help to standardize measurement techniques and parameters. An interactive calibration session will enable the investigator to quantitate the measurement variability among and between assessors and enable the optimization of the measurement process. The main supervisor will solve any conflict that may arise between the assessors by repeating the assessing and giving the final opinion.
Primary Purpose: Treatment
Official Title: One Year Clinical Evaluation of Pressed BioHPP Polyether Ether Ketone (PEEK)-Based Versus Zirconia-Based Single Crowns (Randomized Controlled Clinical Trial)
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
Experimental: BioHPP PEEK single posterior crowns
BioHPP PEEK copings veneered with composite resin
Other: BioHPP PEEK single posterior crowns
BioHPP is a 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymeric material, used for fabrication of high strength fixed and removable prostheses. it has advantages of bio-compatibility, low density, light weight, shock absorption.
Other Name: BioHPP PEEk copings veneered with composite resin

Active Comparator: zirconia-based single posterior crowns
yttria stabilized tetragonal zirconia used as copings to be veneered with porcelain
Other: zirconia-based single posterior crowns
ZrO2, a ceramic material used for medical devices, displays good esthetic appearance, high mechanical strength, and high biocompatibility and is used in a wide range of indications, such as frameworks, implants, and abutments. In addition, it's very good long-term stability and reliability was proven in a 10-year clinical study. These excellent material properties and the transformation behavior are explained by the yttrium oxide stabilization of ZrO2.
Other Name: zirconia copings veneered with porcelain




Primary Outcome Measures :
  1. Fracture [ Time Frame: one year ]
    Fracture of the single crowns assessed by modified Ryge criteria (Alpha, Bravo, Charlie and Delta)


Secondary Outcome Measures :
  1. Marginal adaptation [ Time Frame: one year ]
    Marginal adaptation assessed by modified Ryge criteria (Alpha, Bravo, Charlie and Delt


Other Outcome Measures:
  1. patient satisfaction [ Time Frame: one year ]
    patient satisfaction assessed by VAS questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  8. Failed endodotically treated teeth; short or overextended, narrow, missed canal, ledge or perforated teeth (even if no clear symptoms for failure)

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Responsible Party: Aya Ezzat Mohamed Ali El-shimy, Assistant lecturer, fixed prosthodontic department, faculty of dentistry, Cairo University
ClinicalTrials.gov Identifier: NCT03697005     History of Changes
Other Study ID Numbers: CEBD-CU-2018-09-40
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ether
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs