Clinical trial NCT03086928: One Year Clinical Evaluation of E-max CAD and Lava Ultimate Laminate Veneers
Official title: One Year Clinical Evaluation of E-max CAD and Lava Ultimate Laminate Veneers With Butt Joint Preparation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Discoloration, Tooth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient satisfaction evaluated by using a questionnaire
timeFrame: one year
Secondary outcomes:
measure: Modified USPHS criteria
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: amina zaki, PHD
role: STUDY_CHAIR
References:
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. Epub 2015 Dec 3.
citation: 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. Epub 2011 Jul 20.