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

NCT ID: NCT03086928

Last Updated: 2017-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-30

Study Completion Date

2018-04-30

Brief Summary

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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

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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.

Conditions

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Discoloration, Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
double blinded

Study Groups

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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.

Group Type EXPERIMENTAL

lava ultimate

Intervention Type OTHER

resin nano ceramic material

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

Group Type ACTIVE_COMPARATOR

E.max cad

Intervention Type OTHER

Lithium disilicate glass ceramic

Interventions

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lava ultimate

resin nano ceramic material

Intervention Type OTHER

E.max cad

Lithium disilicate glass ceramic

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mai Mohamed Eltohami

Dentist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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amina zaki, PHD

Role: STUDY_CHAIR

Cairo University

Central Contacts

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mai elgendi, B.D.S

Role: CONTACT

201126811001

kareem abo bakr, PHD

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 26633080 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21773711 (View on PubMed)

Other Identifiers

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CEBC-CU-2017-3-12

Identifier Type: -

Identifier Source: org_study_id

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