NCT02943395

Brief Summary

Light curing cements used for laminate veneers may be not totally cured in certain areas, so dual cured resin cements may solve this problem yet the dual cured cements containing amines cause yellowish discoloration of the veneers after time. A new dual cured cement which is amine free is introduced so the investigators have to try it clinically using parallel groups in randomized clinical trial.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

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

October 19, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Last Updated

October 24, 2016

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

October 19, 2016

Last Update Submit

October 21, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Color stability assessed clinically using easy shade vita device

    Color stability

    1 Year

Secondary Outcomes (1)

  • Patient satisfaction assessed using a Questionnaire

    1 Year

Study Arms (2)

dual cure amine free adhesive resin cement

EXPERIMENTAL

resin cement that get activated by both light and chemicals

Other: E.Max CAD Laminate Veneers cemented with dual cure amine free adhesive resin cement

light cured adhesive resin cement

ACTIVE COMPARATOR

resin cement that only get activated by light

Other: E.Max CAD Laminate Veneers cemented with light cured adhesive resin cement

Interventions

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All subjects are required to be:
  • From 18-60 years old, and able to read and sign the informed consent document
  • 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, fracture not involve more than 50% enamel loss, mild malposition, ….)
  • 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 50% 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)

  • Magalhaes AP, Cardoso Pde C, de Souza JB, Fonseca RB, Pires-de-Souza Fde C, Lopez LG. Influence of activation mode of resin cement on the shade of porcelain veneers. J Prosthodont. 2014 Jun;23(4):291-5. doi: 10.1111/jopr.12098. Epub 2013 Oct 7.

    PMID: 24118675BACKGROUND
  • Gresnigt MM, Kalk W, Ozcan M. Clinical longevity of ceramic laminate veneers bonded to teeth with and without existing composite restorations up to 40 months. Clin Oral Investig. 2013 Apr;17(3):823-32. doi: 10.1007/s00784-012-0790-5. Epub 2012 Jul 21.

    PMID: 22821429BACKGROUND

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Central Study Contacts

Mahmoud Elkomy, B.D.s

CONTACT

Jylan elguindy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dentist at egyption ministry of health

Study Record Dates

First Submitted

October 19, 2016

First Posted

October 24, 2016

Study Start

January 1, 2017

Primary Completion

March 1, 2018

Last Updated

October 24, 2016

Record last verified: 2016-10