Clinical Evaluation of the Fracture Resistance for E-max Cad and Vita Suprinity Laminate Veneers

Tooth Discoloration Clinical Trial

Official title:

Clinical Evaluation of the Fracture Resistance for E-max Cad and Vita Suprinity Laminate Veneers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02940717
• Other study ID #: emax_vita
• Status: Active, not recruiting
• Phase: N/A
• First received: October 19, 2016
• Last updated: July 18, 2017
• Start date: January 2017
• Est. completion date: March 2018

Study information

• Verified date: July 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients need laminate veneer for their teeth usually use Emax CAD as an etchable ceramic. Yet fracture may occur so a stronger material is needed. Vita Suprinity is a recent material with glass ceramic enriched with zirconia (approx. 10% by weight) that offer practices and laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS) and can be used to fabricate laminate veneers but the investigators have to know clinically it is fracture resistance, so the investigators are going to have Parallel groups in a randomized clinical trial.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: March 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

All subjects are required to be:

• From 18-60 years old, and able to read and sign the informed consent document.

• Physically and psychologically able to tolerate conventional restorative procedures

• Have no active periodontal or pulpal diseases, have teeth with good restorations

• Patients with teeth problems indicated for laminate veneer (e.g. discoloration, fracture not involve more than 50% enamel loss, mild malposition, ….)

• Willing to return for follow-up examinations and evaluation

Exclusion Criteria:

• Patients in the growth stage with partially erupted teeth

• Patient with fractured teeth of more than 50% enamel loss

• Patients with poor oral hygiene and motivation

• Pregnant women

• Psychiatric problems or unrealistic expectations

• Lack of opposite occluding dentition in the area intended for restoration

Related Conditions & MeSH terms

• Tooth Discoloration

Intervention

Other:
• Vita suprinity
New glass ceramic material
• Emax CAD
standard etchable glass ceramic used for laminate venneers

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (3)

Elsaka SE, Elnaghy AM. Mechanical properties of zirconia reinforced lithium silicate glass-ceramic. Dent Mater. 2016 Jul;32(7):908-14. doi: 10.1016/j.dental.2016.03.013. Epub 2016 Apr 14. — View Citation

Gresnigt MM, Kalk W, Özcan M. Clinical longevity of ceramic laminate veneers bonded to teeth with and without existing composite restorations up to 40 months. Clin Oral Investig. 2013 Apr;17(3):823-32. doi: 10.1007/s00784-012-0790-5. Epub 2012 Jul 21. — View Citation

Weyhrauch M, Igiel C, Scheller H, Weibrich G, Lehmann KM. Fracture Strength of Monolithic All-Ceramic Crowns on Titanium Implant Abutments. Int J Oral Maxillofac Implants. 2016 Mar-Apr;31(2):304-9. doi: 10.11607/jomi.4601. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fracture resistance assessed by clinical evaluation using dental mirror and probe according to the modified united states public health criteria	clinical evaluation of Fracture resistance	1 Year
Secondary	Patient satisfaction assessed using a Questionnaire	Questionnaire for patient satisfaction	1 Year