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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02994862
Other study ID # 1226500339
Secondary ID
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


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
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