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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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04738513
Enrollment
40
Registered
2021-02-04
Start date
2021-03-01
Completion date
2022-07-01
Last updated
2021-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Badly Decayed Teeth, Endodontically Treated Teeth, Malposed Teeth(Tilted,Overerupted,Totated,Etc.), Single Anterior Crowns, Spacing Between Anterior Teeth

Brief summary

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).

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.

Interventions

PROCEDUREVertical preparation technique

Teeth in dental esthetic zone will receive Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using vertical preparation technique.

PROCEDUREConventional Preparation technique

Teeth in dental esthetic zone will receive Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using conventional preparation technique.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Marginal integrity1 yearMeasured 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)

Secondary

MeasureTime frameDescription
Gingival discoloration1 yearMeasured 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
Gingival inflammation1 yearMeasured by using Modified United States Public Health Service criteria (USPHS criteria) Alpha (A) Non, Bravo (B) Slight, Charlie (C) Moderate, Delta (D) Severe
Restoration color stability1 yearMeasured by using Modified United States Public Health Service criteria (USPHS criteria) Alpha(A) No change, Bravo(B) change in comparison to baseline condition
Secondary caries1 yearMeasured by using Modified United States Public Health Service criteria (USPHS criteria) Alpha (A) Non, Bravo (B) Caries present
patient satisfaction1 yearMeasured by Visual Analog Scale VAS (Questionnaire) a numerical scale from (0 unsatisfied to 10 satisfied)

Countries

Egypt

Contacts

Primary ContactMenna ElGendy, MSD
mennaelgendy@dentisrty.cu.edu.eg00201093302027
Backup ContactRana Sherif, Professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026