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

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

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.

Study Overview

• Status: Unknown
• Conditions: Discoloration, Tooth
• Intervention / Treatment: Other: lava ultimate; Other: E.max cad

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.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mai elgendi, B.D.S; Phone Number: 201126811001; Email: mai.eltohami@dentistry.cu.edu.eg
• Study Contact Backup: Name: kareem abo bakr, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: lava ultimate; lava ultimate is Resin nano-ceramic which 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.	Other: lava ultimate; resin nano ceramic material
ACTIVE_COMPARATOR: E.max cad; E.max is lithium disilicate glass ceramic, composed of quartz, lithium dioxide, phosphor oxide, alumina oxide, and potassium oxide with superior mechanical and optical properties if used for laminate veneers	Other: E.max cad; Lithium disilicate glass ceramic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: amina zaki, PHD, Cairo University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2017
• Primary Completion (ANTICIPATED): April 1, 2018
• Study Completion (ANTICIPATED): April 1, 2018

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: March 16, 2017
• First Posted (ACTUAL): March 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Discoloration
• Other Study ID Numbers: CEBC-CU-2017-3-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No