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Status unknownNCT03295513Updated Sep 28, 2017

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

An interventional study of Veneered zirconia and Monolithic zirconia in Broken Tooth With Complication, Non Vital Teeth and Mutilated Teeth, sponsored by Cairo University. Status unknown. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-28.

Sponsored by Cairo University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Broken Tooth With Complication
  • Non Vital Teeth
  • Mutilated Teeth

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Keywords

  • mutilated, root canal treated teeth, and coronal fracture
03

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
26 participants (estimated)

Study arms

  • Active comparator
    veneered zirconia full coverage restorations

    InCoris zirconia material (TZI-Densupply sirona)

    Other: Veneered zirconia

  • Experimental
    Monolithic zirconia full coverage restorations

    InCoris (TZI-Densupply sirona)

    Other: Monolithic zirconia

Interventions

  • OtherVeneered 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

  • OtherMonolithic zirconia

    Monolithic zirconia product presented a new generation of polycrystalline material by which full anatomical crowns and bridges can be produced

05

What researchers measure

Primary outcomes

  1. Chipping

    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.

    Time frame: 12 month

Secondary outcomes

  1. tooth wear

    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.

    Time frame: 12 month

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03295513
Lead sponsor
Cairo University
Responsible party
Nouran Mahmoud Ibrahim Metwally (mSc, Cairo University) — Principal investigator
First posted
Sep 28, 2017
Start date
Nov 1, 2017 (estimated)
Primary completion
Dec 1, 2018 (estimated)
Completion
Feb 1, 2019 (estimated)
Last update
Sep 28, 2017

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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