Status unknownNCT02994862Updated Dec 16, 2016

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

An interventional study of Galla Chinnesis and Conventional Bonding in Amelogenesis Imperfecta, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-12-16.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2016), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 16
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study 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

Read the 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

Conditions studied

Amelogenesis Imperfecta

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 16 participants (estimated)

Study arms

Experimental
Galla Chinnesis
new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta
Other: Galla Chinnesis
Active comparator
Conventional Bonding
Normal Bonding Method
Other: Conventional Bonding

Interventions

OtherGalla Chinnesis
new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta
OtherConventional Bonding
Normal Bonding Protocol

What researchers measure

Primary outcomes

marginal adaptation assessed by clinical evaluation using dental mirror and probe
clinical evaluation of marginal adaptation
Time frame: 1 year

Secondary outcomes

Patient satisfaction assessed using a Questionnaire
Questionnaire for patient satisfaction
Time frame: 1 Year

Study locations

No study locations are listed for this record.

References and documents

Publications

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. PubMed 20690414 ↗

Individual participant data

Plan to share: Undecided

Registry details

Key details

Study ID: NCT02994862
Lead sponsor: Cairo University
Responsible party: Mohammed Gamal Fahmy Mohammed (B.D.S, Cairo University) — Principal investigator
First posted: Dec 16, 2016
Start date: Dec 2016
Primary completion: Dec 2017 (estimated)
Completion: Dec 2017 (estimated)
Last update: Dec 16, 2016

Study contacts

Mohammed mohammed, B.D.S

Contact

mgamal400@gmail.com

01226500339

Jylan Elguindy, Phd

Contact

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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Other studies in this condition

Amelogenesis Imperfecta

Other studies from this sponsor

Cairo University

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