Color Stability of E.Max CAD Laminate Veneers Cemented With Light Cure Versus Dual Cure Amine Free Adhesive Resin Cement

Tooth Discoloration Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02943395
• Other study ID #: 17191405
• Status: Not yet recruiting
• Phase: N/A
• First received: October 19, 2016
• Last updated: October 21, 2016
• Start date: January 2017

Study information

• Verified date: October 2016
• Source: Cairo University
• Contact: Mahmoud Elkomy, B.D.s
• Phone: 01113735370
• Email: mahmoud.hossam919[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Light curing cements used for laminate veneers may be not totally cured in certain areas, so dual cured resin cements may solve this problem yet the dual cured cements containing amines cause yellowish discoloration of the veneers after time.

A new dual cured cement which is amine free is introduced so the investigators have to try it clinically using parallel groups in randomized clinical trial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• 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

Study Design

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

Related Conditions & MeSH terms

• Tooth Discoloration

Intervention

Other:
• E.Max CAD Laminate Veneers cemented with dual cure amine free adhesive resin cement

• E.Max CAD Laminate Veneers cemented with light cured adhesive resin cement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

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

Magalhães AP, Cardoso Pde C, de Souza JB, Fonseca RB, Pires-de-Souza Fde C, Lopez LG. Influence of activation mode of resin cement on the shade of porcelain veneers. J Prosthodont. 2014 Jun;23(4):291-5. doi: 10.1111/jopr.12098. Epub 2013 Oct 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Color stability assessed clinically using easy shade vita device	Color stability	1 Year	No
Secondary	Patient satisfaction assessed using a Questionnaire	Questionnaire for the patient satisfaction	1 Year	No