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

Personal Satisfaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02846116
• Other study ID #: CEBD-2016-7-170
• Status: Not yet recruiting
• Phase: N/A
• First received: July 19, 2016
• Last updated: October 15, 2016
• Start date: December 2016
• Est. completion date: July 2017

Study information

• Verified date: October 2016
• Source: Cairo University
• Contact: Sameh Sh Abou-Steit, Master
• Phone: +201001891010
• Email: samehabousteit[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Personal Satisfaction

Intervention

Other:
• Prosthetic crown

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (10)

Al-Wahadni A, Ajlouni R, Al-Omari Q, Cobb D, Dawson D. Shade-match perception of porcelain-fused-to-metal restorations: a comparison between dentist and patient. J Am Dent Assoc. 2002 Sep;133(9):1220-5; quiz 1260-1. — View Citation

Batson ER, Cooper LF, Duqum I, Mendonça G. Clinical outcomes of three different crown systems with CAD/CAM technology. J Prosthet Dent. 2014 Oct;112(4):770-7. doi: 10.1016/j.prosdent.2014.05.002. Epub 2014 Jun 28. — View Citation

Corciolani G, Vichi A, Louca C, Ferrari M. Color match of two different ceramic systems to selected shades of one shade guide. J Prosthet Dent. 2011 Mar;105(3):171-6. doi: 10.1016/S0022-3913(11)60025-5. — View Citation

Dr Rupal J Shah1. A Study of Patient Satisfaction with Maxillary Anterior Teeth Restorations and Desirable Esthetic Treatment Options\n. IOSR J. Dent. Med. Sci. 13, 79-86 (2014).

Etman MK, Woolford MJ. Three-year clinical evaluation of two ceramic crown systems: a preliminary study. J Prosthet Dent. 2010 Feb;103(2):80-90. doi: 10.1016/S0022-3913(10)60010-8. — View Citation

Grossmann AC, Hassel AJ, Schilling O, Lehmann F, Koob A, Rammelsberg P. Treatment with double crown-retained removable partial dentures and oral health-related quality of life in middle- and high-aged patients. Int J Prosthodont. 2007 Nov-Dec;20(6):576-8. — View Citation

Ishikawa-Nagai S, Yoshida A, Sakai M, Kristiansen J, Da Silva JD. Clinical evaluation of perceptibility of color differences between natural teeth and all-ceramic crowns. J Dent. 2009;37 Suppl 1:e57-63. doi: 10.1016/j.jdent.2009.04.004. Epub 2009 Apr 18. — View Citation

John MT, Slade GD, Szentpétery A, Setz JM. Oral health-related quality of life in patients treated with fixed, removable, and complete dentures 1 month and 6 to 12 months after treatment. Int J Prosthodont. 2004 Sep-Oct;17(5):503-11. — View Citation

Samorodnitzky-Naveh GR, Geiger SB, Levin L. Patients' satisfaction with dental esthetics. J Am Dent Assoc. 2007 Jun;138(6):805-8. — View Citation

Tin-Oo MM, Saddki N, Hassan N. Factors influencing patient satisfaction with dental appearance and treatments they desire to improve aesthetics. BMC Oral Health. 2011 Feb 23;11:6. doi: 10.1186/1472-6831-11-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction using Visual Analogue scale- Binary (Satisfied or not satisfied)		1 year	No
Secondary	Shade matchUsing the modified United States Public Health Service criteria (Modified USPHS)- categorical		1 year	No