NCT03086928

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

March 9, 2017

Last Update Submit

March 16, 2017

Conditions

Discoloration, Tooth

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Modified USPHS criteria

    one year

Study Arms (2)

lava ultimate

EXPERIMENTAL

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

E.max cad

ACTIVE COMPARATOR

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

Interventions

lava ultimateOTHER

resin nano ceramic material

lava ultimate
E.max cadOTHER

Lithium disilicate glass ceramic

E.max cad

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • From 18-50 years old, be able to read and sign the informed consent document.
  • Be 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, defect not involve more than 60% enamel loss, mild malposition, anterior upper….).
  • Be willing to return for follow-up examinations and evaluation.

You may not qualify if:

  • Patients in the growth stage with partially erupted teeth.
  • Patient with fractured teeth of more than 60% 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 26633080BACKGROUND

  • 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.

    PMID: 21773711BACKGROUND

MeSH Terms

Conditions

Tooth Discoloration

Interventions

IPS e.max CAD LT

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • amina zaki, PHD

    Cairo University

    STUDY CHAIR

Central Study Contacts

mai elgendi, B.D.S

CONTACT

201126811001mai.eltohami@dentistry.cu.edu.eg

kareem abo bakr, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 22, 2017

Study Start

April 1, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

March 22, 2017

Record last verified: 2017-03