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Trial record 10 of 119 for:    ZIRCONIUM

Clinical Evaluation of Wear Behavior of Human Enamel and Chipping of Veneered Zirconia Against Monolithic Zirconia

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ClinicalTrials.gov Identifier: NCT03295513
Recruitment Status : Unknown
Verified September 2017 by Nouran Mahmoud Ibrahim Metwally, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : September 28, 2017
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Nouran Mahmoud Ibrahim Metwally, Cairo University

Brief Summary:
The aim of this study is to evaluate chipping and the degree of natural enamel loss opposing to monolithic zirconia compared to veneered zirconia restoration.

Condition or disease Intervention/treatment Phase
Broken Tooth With Complication Non Vital Teeth Mutilated Teeth Other: Veneered zirconia Other: Monolithic zirconia Not Applicable

Detailed Description:

While increase using of zirconia in extra coronal restoration as a substitute for metal ceramic restoration still high rate of technical complications specifically chipping of veneering ceramic and wear of antagonist are usually associated with veneered zirconia restoration which led to development of new monolithic zirconia to overcome these technical complications.

Therefore this study will be conducted to evaluate chipping and wear of antagonist of veneered zirconia versus monolithic zirconia all ceramic crowns in posterior area.

Benefits of the research to the patient:

Patient will receive a restoration with superior function, esthetics, and quality.

It will save teeth such as mutilated teeth, endodontically treated and teeth with massive loss of tooth structure that cannot be restored with direct restoration.

As a result of properly functioning restoration, teeth will be restored with predictable prognosis and the patient will be psychologically improved.

Benefits of the research to the clinician:

Practitioner will have the advantage to clinically assess a new material that can be used in different situations for better function and esthetic outcomes.

It will improve patient confidence with the dentist.

Explanation for choice of comparators:

The use of veneered zirconia is well documented in the literatures as successful restoration modality. A two Clinical performance of two different CAD/CAM-fabricated ceramic crowns revealed no chipping for veneered zirconia.

A 3 years Randomized Controlled Clinical Trial of Zirconia-Ceramic and Metal-Ceramic Posterior Fixed Dental Prostheses reported Alpha Scores A=66.6%, B =25% , C=5.6% and Only D= 2.8 A 5 years prospective clinical study of posterior zirconia fixed dental prosthesis reported Alpha scores greater than 95% indicating no predictable changes during the 5 years Another 3 years Randomized controlled clinical Trial of Posterior veneered zirconia for fixed dental prostheses revealed 20% chipping and also 30% reported alpha for antagonist wear and 70% reported bravo after 3 years of clinical use.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patient will receive a restoration with superior function, esthetics, and quality.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Clinical Evaluation of Wear Behavior of Human Enamel and Chipping of Veneered Zirconia Against Monolithic Zirconia (Randomized Controlled Clinical Trial)
Estimated Study Start Date : November 1, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
Active Comparator: veneered zirconia full coverage restorations
InCoris zirconia material (TZI-Densupply sirona)
Other: Veneered zirconia
he use of veneered zirconia is well documented in the literatures as successful restoration modality. A two Clinical performance of two different CAD/CAM-fabricated ceramic crowns revealed no chipping for veneered zirconia

Experimental: Monolithic zirconia full coverage restorations
InCoris (TZI-Densupply sirona)
Other: Monolithic zirconia
Monolithic zirconia product presented a new generation of polycrystalline material by which full anatomical crowns and bridges can be produced




Primary Outcome Measures :
  1. Chipping [ Time Frame: 12 month ]
    chipping of the restoration by modified USPHs criteria as Alpha (Excellent) ideal,Bravo (Acceptable) less than ideal but no modifications required, Charlie (Acceptable but modifications needed) staining or other shade modifications required, and Delta (Unacceptable) remake.


Secondary Outcome Measures :
  1. tooth wear [ Time Frame: 12 month ]
    Measuring the effect on natural tooth by modified USPHs criteria as Alpha(Excellent) ideal,Bravo (Acceptable) less than ideal but no modifications requiredCharlie (Acceptable but modifications needed) staining or other shade modifications required, and Delta (Unacceptable) remake.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age range of the patients from 20-60 years old; able to read and sign the informed consent document, illiterate patient will be avoided.
  2. Patients able physically and psychologically to tolerate conventional restorative procedures.
  3. Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
  4. Patients with teeth problems indicated for full coverage restoration (e.g. Moderate to severe discoloration, coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
  5. Patients with root canal treated teeth requiring full coverage restorations.
  6. Patients willing to return for follow-up examinations and evaluation.

Exclusion Criteria:

  1. Patients in the growth stage with partially erupted teeth.
  2. Patients with poor oral hygiene and motivation.
  3. A pregnant woman's to avoid any complication that may occur in dental office due to pregnancy or due to injected anesthetic solution.
  4. Patients with psychiatric problems or unrealistic expectation (patient that has phobia from dental treatments or needle bunch).
  5. Patients have no opposite occluding dentition in the area intended for restoration.
  6. Patients suffer from Para functional habits.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295513


Contacts
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Contact: Nouran M Ibrahim 01149928886 ext +20 nouran.mahmoud@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University

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Responsible Party: Nouran Mahmoud Ibrahim Metwally, mSc, Cairo University
ClinicalTrials.gov Identifier: NCT03295513     History of Changes
Other Study ID Numbers: CEBD-CU-2017-09-21
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nouran Mahmoud Ibrahim Metwally, Cairo University:
mutilated, root canal treated teeth, and coronal fracture
Additional relevant MeSH terms:
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Tooth, Nonvital
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases