One Year Clinical Evaluation of E-max CAD and Lava Ultimate Laminate Veneers

Discoloration, Tooth Clinical Trial

Official title:

One Year Clinical Evaluation of E-max CAD and Lava Ultimate Laminate Veneers With Butt Joint Preparation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03086928
• Other study ID #: CEBC-CU-2017-3-12
• Status: Not yet recruiting
• Phase: N/A
• First received: March 9, 2017
• Last updated: March 16, 2017
• Start date: April 2017
• Est. completion date: April 2018

Study information

• Verified date: March 2017
• Source: Cairo University
• Contact: mai elgendi, B.D.S
• Phone: 201126811001
• Email: mai.eltohami[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Restoration of anterior teeth using conservative approach allows clinicians to provide porcelain laminate veneers with excellent esthetics without extensive tooth structure removal. laminate veneers need the use of etch-able ceramics like glass ceramics (E.max) and hybrid ceramics (Lava Ultimate). The aim of this study is to compare both e.max and lava ultimate veneers clinically.

Description:

The use of E-max CAD well documented in the literatures as successful restoration modality which has superior optical and mechanical properties. The introduction of hybrid ceramic materials combined the advantages of both glass ceramics and composite resin. Resin nano-ceramic is a mixture of a resin composite matrix and nano-ceramic fillers of approximately 80% by weight. The main advantages of this material over the glass ceramics are the stress absorbing action or stress distribution by having modulus of elasticity near to the tooth dentin and can be individualized intra-orally or extra-orally, either before or after definitive cementation.

Yet there are no studies for clinical evaluation of both mentioned laminate veneers restorations. This study is conducted to compare between both materials clinically according to modified USPHS criteria in terms of marginal adaptation, fracture, debonding, marginal discoloration and patient satisfaction.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. From 18-50 years old, be able to read and sign the informed consent document.

2. Be physically and psychologically able to tolerate conventional restorative procedures.

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

4. Patients with teeth problems indicated for laminate veneer (e.g. discoloration, defect not involve more than 60% enamel loss, mild malposition, anterior upper….).

5. Be willing to return for follow-up examinations and evaluation.

Exclusion Criteria:

1. Patients in the growth stage with partially erupted teeth.

2. Patient with fractured teeth of more than 60% enamel loss.

3. Patients with poor oral hygiene and motivation.

4. Pregnant women.

5. Psychiatric problems or unrealistic expectations.

6. Lack of opposite occluding dentition in the area intended for restoration.

Related Conditions & MeSH terms

• Discoloration, Tooth
• Tooth Discoloration

Intervention

Other:
• lava ultimate
resin nano ceramic material
• E.max cad
Lithium disilicate glass ceramic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

D'Arcangelo C, De Angelis F, Vadini M, D'Amario M. Clinical evaluation on porcelain laminate veneers bonded with light-cured composite: results up to 7 years. Clin Oral Investig. 2012 Aug;16(4):1071-9. doi: 10.1007/s00784-011-0593-0. — View Citation

Pimentel W, Teixeira ML, Costa PP, Jorge MZ, Tiossi R. Predictable Outcomes with Porcelain Laminate Veneers: A Clinical Report. J Prosthodont. 2016 Jun;25(4):335-40. doi: 10.1111/jopr.12413. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction evaluated by using a questionnaire	Patient satisfaction will be evaluated by using a questionnaire, which will be translated. A validation of the Arabic translation will be done before using the questionnaire in the trial. Each participant will take the questionnaire into a quiet room and will be left alone until questionnaire is totally answered.	one year
Secondary	Modified USPHS criteria	It is a criteria for clinical evaluation of dental restorative materials in terms of marginal adaptation, marginal discoloration, fracture, debonding.	one year