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E. Max Laminate Veneers With and Without Using Galla Chinnesis as Natural Cross Linking and Remineralizing Agent

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ClinicalTrials.gov Identifier: NCT02994862
Recruitment Status : Unknown
Verified December 2016 by Mohammed Gamal Fahmy Mohammed, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : December 16, 2016
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
Mohammed Gamal Fahmy Mohammed, Cairo University

Brief Summary:
In teeth requiring laminate veneers with amelogenesis imperfecta Will application of galla chinensis before Bonding of laminate veneers with adhesive resin cement provide better survival rate than conventional Bonding method

Condition or disease Intervention/treatment Phase
Amelogenesis Imperfecta Other: Galla Chinnesis Other: Conventional Bonding Not Applicable

Detailed Description:
one year Clinical evaluation of laminate veneers with amelogenesis imperfecta Will application of galla chinensis before Bonding of laminate veneers with adhesive resin cement provide better survival rate than conventional Bonding method

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: One Year Clinical Evaluation of E. Max Laminate Veneers With and Without Using Galla Chinnesis as Natural Cross Linking and Remineralizing Agent Before Bonding to Teeth With Amelogenesis Imperfecta
Study Start Date : December 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Galla Chinnesis
new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta
Other: Galla Chinnesis
new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta

Active Comparator: Conventional Bonding
Normal Bonding Method
Other: Conventional Bonding
Normal Bonding Protocol




Primary Outcome Measures :
  1. marginal adaptation assessed by clinical evaluation using dental mirror and probe [ Time Frame: 1 year ]
    clinical evaluation of marginal adaptation


Secondary Outcome Measures :
  1. Patient satisfaction assessed using a Questionnaire [ Time Frame: 1 Year ]
    Questionnaire for patient satisfaction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994862


Contacts
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Contact: Mohammed mohammed, B.D.S 01226500339 mgamal400@gmail.com
Contact: Jylan Elguindy, Phd

Sponsors and Collaborators
Cairo University

Publications:
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Responsible Party: Mohammed Gamal Fahmy Mohammed, B.D.S, Cairo University
ClinicalTrials.gov Identifier: NCT02994862     History of Changes
Other Study ID Numbers: 1226500339
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Amelogenesis Imperfecta
Dental Enamel Hypoplasia
Tooth Abnormalities
Stomatognathic System Abnormalities
Stomatognathic Diseases
Tooth Diseases
Congenital Abnormalities