One Year Clinical Evaluation of New Gradient Technology Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns in Dental Esthetic Zone With Vertical Versus Conventional Preparation Techniques

One Year Clinical Evaluation of New Gradient Technology Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns in Dental Esthetic Zone With Vertical Versus Conventional Preparation Techniques (Randomized Clinical Trial)

The aim of this study is to evaluate the clinical behavior of zirconia crowns in dental esthetic zone with vertical versus conventional preparation techniques using a new gradient technology monolithic zirconia (5Y-TZP/3Y-TZP).

Study Overview

• Status: Recruiting
• Conditions: Endodontically Treated Teeth; Badly Decayed Teeth; Single Anterior Crowns; Spacing Between Anterior Teeth; Malposed Teeth(Tilted,Overerupted,Totated,Etc.)
• Intervention / Treatment: Procedure: Conventional Preparation technique; Procedure: Vertical preparation technique

Detailed Description

Introduction: A good relationship between dental restorations and the periodontium is one of the most important aspects to ensure clinical success both in terms of esthetics and function. Dental preparation for fixed prostheses can take various forms classified as horizontal preparation with a defined margin (chamfer), or vertical, or without a margin/finish line. According to some clinical reports, vertical preparation technique provides an increases in the gingival thickness and a greater stability of the gingival margin. Moreover, vertical preparation is characterized by being more conservative with tooth structure. Also, taking impressions is easier since it is a finish area and not a defined line.

Null hypothesis:

1. There will be no difference between vertical and conventional preparations in the clinical behavior of zirconia crowns in dental esthetic zone at baseline,3,6,9,12 months evaluation.
2. There will be no difference between vertical and conventional preparations in the patient satisfaction of zirconia crowns in dental esthetic zone at baseline,3,6,9,12 months evaluation.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Menna ElGendy, MSD; Phone Number: 00201093302027; Email: mennaelgendy@dentisrty.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11865
    • Recruiting
    • Cairo University
    • Contact: Menna ElGendy, Master; Phone Number: 00201093302027; Email: mennaelgendy@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. From 21-50 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 all ceramic crowns in esthetic zone;

   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.)
5. Able to return for follow-up examinations and evaluation.
6. Thick gingival biotype.

Exclusion Criteria:

1. Patient less than 21or 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. Patient with periodontal problems.
8. Patients with malocclusion or parafunctional habits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional preparation technique; Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using conventional preparation technique.	Procedure: Conventional Preparation technique; Teeth in dental esthetic zone will receive Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using conventional preparation technique.
Experimental: Vertical preprartion; Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using Vertical preparation technique.	Procedure: Vertical preparation technique; Teeth in dental esthetic zone will receive Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using vertical preparation technique.; Other Names: Vertiprep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal integrity	Measured by using Modified United States Public Health Service criteria (USPHS criteria); Alpha (A) the explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does not catch, there is no visible crevice along the periphery of the restoration (visual inspection explorer); Bravo (B) the explorer catches and the is visible evidence of the crevice, which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure. The dentin and/or the base is not exposed, and the restoration is not mobile ( visual inspection and explorer); Charlie (C) the explorer penetrates crevice defect extended to the dento-enamel junction (explorer)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival discoloration	Measured by using Modified United States Public Health Service criteria (USPHS criteria); Alpha (A) None,; Bravo (B) Slight discoloration, removable by finishing,; Charlie (C) Discoloration, localized not removable,; Delta (D) Strong discoloration in major parts of the margin not removable	1 year
Gingival inflammation	Measured by using Modified United States Public Health Service criteria (USPHS criteria) Alpha (A) Non, Bravo (B) Slight, Charlie (C) Moderate, Delta (D) Severe	1 year
Restoration color stability	Measured by using Modified United States Public Health Service criteria (USPHS criteria) Alpha(A) No change, Bravo(B) change in comparison to baseline condition	1 year
Secondary caries	Measured by using Modified United States Public Health Service criteria (USPHS criteria) Alpha (A) Non, Bravo (B) Caries present	1 year
patient satisfaction	Measured by Visual Analog Scale VAS (Questionnaire) a numerical scale from ("0" unsatisfied to "10" satisfied)	1 year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: January 31, 2021
• First Submitted That Met QC Criteria: January 31, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Pulp Diseases; Dental Caries; Tooth, Nonvital
• Other Study ID Numbers: 351020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No