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

Amelogenesis Imperfecta Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02994862
• Other study ID #: 1226500339
• Status: Not yet recruiting
• Phase: N/A
• First received: December 8, 2016
• Last updated: December 13, 2016
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Cairo University
• Contact: Mohammed mohammed, B.D.S
• Phone: 01226500339
• Email: mgamal400[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amelogenesis Imperfecta

Intervention

Other:
• Galla Chinnesis
new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta
• Conventional Bonding
Normal Bonding Protocol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	marginal adaptation assessed by clinical evaluation using dental mirror and probe	clinical evaluation of marginal adaptation	1 year	No
Secondary	Patient satisfaction assessed using a Questionnaire	Questionnaire for patient satisfaction	1 Year	No