E. Max Laminate Veneers With and Without Using Galla Chin... | NCT02994862

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

NCT02994862

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Dec 16, 2016Estimated

Enrollment

16Estimated

Phase

Not Applicable

Conditions

Amelogenesis Imperfecta

Interventions

Galla Chinnesis
Conventional Bonding

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Dec 8, 2016

First Submission Date that Met QC Criteria

Dec 13, 2016

First Posted Date

Dec 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2016

Last Update Posted Date

Dec 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Galla Chinnesis	Experimental	new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta	Other: Galla Chinnesis
Conventional Bonding	Active Comparator	Normal Bonding Method	Other: Conventional Bonding

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Galla Chinnesis	Other	new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta	Galla Chinnesis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
marginal adaptation assessed by clinical evaluation using dental mirror and probe	clinical evaluation of marginal adaptation	1 year

Secondary Outcomes

Measure	Description	Time Frame
Patient satisfaction assessed using a Questionnaire	Questionnaire for patient satisfaction	1 Year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohammed mohammed, B.D.S	Contact	01226500339		mgamal400@gmail.com
Jylan Elguindy, Phd	Contact

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20690414	Background	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.

ID	Term
D000094602	Developmental Defects of Enamel
D014071	Tooth Abnormalities
D018640	Stomatognathic System Abnormalities
D009057	Stomatognathic Diseases