Clinical trial NCT02846116: Evaluation of Patient Satisfaction and Shade Matching of Vita Suprinity Versus Lithium Disilicate (E-max) Ceramic Crowns in Esthetic Zone
Official title: Evaluation of Patient Satisfaction and Shade Matching of Vita Suprinity Versus Lithium Disilicate (E-max) Ceramic Crowns in Esthetic Zone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Personal Satisfaction
Keywords: all ceramic crown
Lithium disilicate
e-max
vita suprinity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient satisfaction using Visual Analogue scale- Binary (Satisfied or not satisfied)
timeFrame: 1 year
Secondary outcomes:
measure: Shade matchUsing the modified United States Public Health Service criteria (Modified USPHS)- categorical
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Oral and Dental Medicine- Cairo University
name: Amina Zaki, Professor
role: STUDY_DIRECTOR
References:
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