E. Max Laminate Veneers With and Without Using Galla Chinnesis as Natural Cross Linking and Remineralizing Agent
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
1 other identifier
interventional
16
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2016
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
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 8, 2016
CompletedFirst Posted
Study publicly available on registry
December 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedDecember 16, 2016
December 1, 2016
1 year
December 8, 2016
December 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
marginal adaptation assessed by clinical evaluation using dental mirror and probe
clinical evaluation of marginal adaptation
1 year
Secondary Outcomes (1)
Patient satisfaction assessed using a Questionnaire
1 Year
Study Arms (2)
Galla Chinnesis
EXPERIMENTALnew Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta
Conventional Bonding
ACTIVE COMPARATORNormal Bonding Method
Interventions
new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta
Eligibility Criteria
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
- Cairo Universitylead
Related Publications (1)
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.
PMID: 20690414BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Jylan Elguindy, Phd
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
- B.D.S
Study Record Dates
First Submitted
December 8, 2016
First Posted
December 16, 2016
Study Start
December 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
December 16, 2016
Record last verified: 2016-12