Evaluation of Patient Satisfaction and Shade Matching of Vita Suprinity Versus Lithium Disilicate (E-max) Ceramic Crowns in Esthetic Zone

October 15, 2016 updated by: Sameh Abou-steit, Cairo University
The aim of this study is to evaluate using of new ceramic material Vita Suprinity and lithium disilicate on patient satisfaction combined with shade matching.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Justification for undertaking the trial:

Nowadays, esthetics has become an important aspect of dentistry due to decrease in caries prevalence and increase in patients' perception of their teeth appearance. Therefore dentists should take into consideration the esthetic needs of the patients during treatment, otherwise patient satisfaction will not be achieved with its subsequent influence on patient self quality of life and psychological status.

As a survey concerning patient satisfaction with regard to dental esthetics issues concluded that color of the restoration plays a primary role for patient satisfaction, as 89.3% of patients were dissatisfied of their dental appearance because of their restorations' color.

Therefore the use of ceramic crowns has increased substantially in recent years because of their superior esthetics and color rendering. In addition to their ability to achieve complete patient satisfaction.

Rationale:

Achieving good esthetic results especially with the continuous innovations of dental ceramic materials is not always easy to achieve and the definitive shade match of porcelain restorations to natural dentition remains a challenge to the dental practitioners and ceramists. Furthermore patient satisfaction to the final outcome is not always in agreement with the clinicians in regard to shade matching decisions.

Therefore this study will be conducted to evaluate patient satisfaction and shade matching of Vita suprinity versus e-max all ceramic crowns in esthetic zone.

Benefits of the research to the patient:

Patient will receive a restoration with superior esthetics, shade match and quality.

It will provide the patient with long-term predictable esthetic restorations As a result of unnoticed perfect esthetic restoration, the patient will be psychologically improved.

Benefits of the research to the clinician:

Practitioner will have the advantage to assess a new material that can be used in different situations for better esthetic outcomes.

It will improve patient confidence with the dentist. It will improve professional skills of the dentist to achieve optimum esthetic results.

Explanation for choice of comparators:

The use of IPS e.max Press is well documented in the literatures as successful restoration modality. A three-year clinical evaluation of two ceramic crown systems revealed excellent color match for the IPS e-max crowns (Alpha for 24 crowns and Bravo for 6 crowns with slight shade mismatches). Also patient questionnaire revealed satisfaction with the appearance and comfort of their restorations.

A 2 years prospective clinical observation study reported Alpha scores (greater than 92%) indicating no appreciable change in the crowns during the two years of the study.

Also the clinical performance of lithium disilicate pressable ceramic crowns revealed a survival rate of 97.4 % after 5 years and 94.8 % after 8 years as reported by Gehrt et al., (2013).

Another 2 years clinical evaluation of lithium disilicate based all ceramic crowns revealed satisfactory clinical performance, with color match Alpha (85%) at baseline, 80% at 1 year recall and 60 % at 2 years recall.

Research hypothesis:

There is difference in the clinical performance of Vita Suprinity if compared with Lithium disilicate ceramic crown restoration if used in esthetic zone.

Interventions:

VITA SUPRINITY: Vita suprinity product Brochure presented a new generation of glass ceramic material. With the aid of an innovative manufacturing process, the glass ceramic is enriched with approximately 10% zirconia by weight, resulting in the world's first zirconia reinforced lithium silicate ceramic (ZLS). The material features a special fine-grained, homogeneous structure that provides excellent material quality and consistency, high load capacity and long term reliability. Moreover, the material offers natural esthetics with successful outcome. Also it offers outstanding processing characteristics, including easy milling and polishing.

Study Type

Interventional

Enrollment (Anticipated)

26

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.

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

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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 (e.g. mild to moderate 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. Pregnant women'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 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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: lithium disilicate
The intervention will be: Prosthetic crown
Other: Prosthetic crown
Other Names:
  • all ceramic crown
ACTIVE_COMPARATOR: Vita suprinity
The intervention will be: Prosthetic crown
Other: Prosthetic crown
Other Names:
  • all ceramic crown

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction using Visual Analogue scale- Binary (Satisfied or not satisfied)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Shade matchUsing the modified United States Public Health Service criteria (Modified USPHS)- categorical
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Amina Zaki, Professor, Faculty of Oral and Dental Medicine- Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2016

Primary Completion (ANTICIPATED)

July 1, 2017

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 24, 2016

First Posted (ESTIMATE)

July 27, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 15, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CEBD-2016-7-170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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