Shade Matching and Patient Satisfaction of Yttria Stabilized Multilayered Zirconia and Lithium Disilicate Restorations

August 7, 2024 updated by: Yasmin Mohamed, Cairo University

Shade Matching and Patient Satisfaction of Yttria Stabilized Multilayered Zirconia and Lithium Disilicate Restorations: a Randomized Controlled Clinical Trial

The aim of the study is to determine whether Yttria stabilized multilayered zirconia restorations will differ from lithium disilicate restorations in shade matching and patient satisfaction in patients requiring full coverage restorations.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Steps in short: Single tooth in the esthetic zone requiring full coverage crown is prepared to receive an all-ceramic crown, The restorations will be divided into two groups: I: Teeth receiving restorations fabricated from Lithium disilicate II: Teeth receiving restorations fabricated from yttria stabilized multilayered zirconia. Shade will be measured using intraoral spectrophotometer and evaluated. The colour difference (ΔE) will be calculated for each sample using the following equation: ΔE =[(ΔL) ²+(Δa) ² + (Δb) ²] ½, ΔE (perceptibility threshold) will be evaluated for each group. Participant timeline the patient will be treated in visits designated as follows: Visit 1: Preoperative records, face-to-face adherence reminder session, clinical, radiographic for examination, intraoral photographs and primary impression (Alginate impression) diagnostic cast construction. Visit 2: teeth preparation and secondary impression using addition silicone rubber base material and temporary restoration. Visit 3: placement and permanent cementation of the final restoration using resin cement.

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 (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. Patients with psychiatric problems or unrealistic expectations (patient that has phobia from dental treatments or needle bunch).
  4. Patients suffer from parafunctional habits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yttria stabilized multilayered (YML) zirconia restorations
Full coverage Yttria stabilized multilayered (YML) zirconia restorations will be fabricated on a tooth requiring full coverage in the esthetic zone.
Other: Yttria stabilized multilayered (YML) zirconia restorations
Yttria stabilized multilayered zirconia restorations were claimed to have high strength and esthetics at the same time but no clinical studies were conducted yet to prove its high esthetic properties
Experimental: Lithium disilicate restorations
Full coverage Lithium disilicate restorations will be fabricated on a tooth requiring full coverage in the esthetic zone.
Other: Lithium disilicate restorations
Lithium disilicate reinforced glass ceramics are considered a gold standard for monolithic esthetic restorations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Color difference
Time Frame: immediate after cementation
By Intraoral Spectrophotometer, color difference between the restoration and the adjacent or contralateral natural tooth will be measured by the unit (ΔE), (ΔE) will be measured for each sample.
immediate after cementation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: immediate after cementation
By Visual Analogue Scale, with score range from 1 to 10 , where 1 is the worst (lowest satisfaction) and 10 is the best (highest satisfaction).
immediate after cementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROSF 3.3.6

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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