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

NCT03295513 | Unknown

• 1 other identifier: CEBD-CU-2017-09-21
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Broken Tooth With Complication; Non Vital Teeth; Mutilated Teeth

Keywords

mutilated, root canal treated teeth, and coronal fracture

Outcome Measures

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.

  12 month

Secondary Outcomes (1)

• tooth wear

  12 month

Study Arms (2)

veneered zirconia full coverage restorations

ACTIVE COMPARATOR

InCoris zirconia material (TZI-Densupply sirona)

Other: Veneered zirconia

Monolithic zirconia full coverage restorations

EXPERIMENTAL

InCoris (TZI-Densupply sirona)

Other: Monolithic zirconia

Interventions

Veneered zirconia OTHER

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

veneered zirconia full coverage restorations

Monolithic zirconia OTHER

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

Monolithic zirconia full coverage restorations

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age range of the patients from 20-60 years old; able to read and sign the informed consent document, illiterate patient will be avoided.
• Patients able physically and psychologically to tolerate conventional restorative procedures.
• Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
• 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).
• Patients with root canal treated teeth requiring full coverage restorations.
• Patients willing to return for follow-up examinations and evaluation.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

Nouran M Ibrahim

CONTACT

01149928886; nouran.mahmoud@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: mSc

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

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 28, 2017
• Study Start: November 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2019
• Last Updated: September 28, 2017

Record last verified: 2017-09