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

Non Vital Teeth Clinical Trial

Official title:

Clinical Evaluation of Wear Behavior of Human Enamel and Chipping of Veneered Zirconia Against Monolithic Zirconia (Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03295513
• Other study ID #: CEBD-CU-2017-09-21
• Status: Not yet recruiting
• Phase: N/A
• First received: September 15, 2017
• Last updated: September 24, 2017
• Start date: November 1, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: September 2017
• Source: Cairo University
• Contact: Nouran M Ibrahim
• Phone: 01149928886
• Email: nouran.mahmoud[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: February 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 month
Secondary	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.	12 month