Back to resultsE. Max Laminate Veneers With and Without Using Galla Chinnesis as Natural Cross Linking and Remineralizing Agent
Primary Purpose
Amelogenesis Imperfecta
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Galla Chinnesis
Conventional Bonding
Sponsored by
About this trial
This is an interventional treatment trial for Amelogenesis Imperfecta
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Galla Chinnesis
Conventional Bonding
Arm Description
new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta
Normal Bonding Method
Outcomes
Primary Outcome Measures
marginal adaptation assessed by clinical evaluation using dental mirror and probe
clinical evaluation of marginal adaptation
Secondary Outcome Measures
Patient satisfaction assessed using a Questionnaire
Questionnaire for patient satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02994862
Brief Title
E. Max Laminate Veneers With and Without Using Galla Chinnesis as Natural Cross Linking and Remineralizing Agent
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 Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amelogenesis Imperfecta
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Galla Chinnesis
Arm Type
Experimental
Arm Description
new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta
Arm Title
Conventional Bonding
Arm Type
Active Comparator
Arm Description
Normal Bonding Method
Intervention Type
Other
Intervention Name(s)
Galla Chinnesis
Intervention Description
new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta
Intervention Type
Other
Intervention Name(s)
Conventional Bonding
Intervention Description
Normal Bonding Protocol
Primary Outcome Measure Information:
Title
marginal adaptation assessed by clinical evaluation using dental mirror and probe
Description
clinical evaluation of marginal adaptation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Patient satisfaction assessed using a Questionnaire
Description
Questionnaire for patient satisfaction
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed mohammed, B.D.S
Phone
01226500339
Email
mgamal400@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jylan Elguindy, Phd
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20690414
Citation
Cheng L, ten Cate JM. Effect of Galla chinensis on the in vitro remineralization of advanced enamel lesions. Int J Oral Sci. 2010 Mar;2(1):15-20. doi: 10.4248/IJOS10019.
Results Reference
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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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