Prevention of incipient carious lesions (white spot lesions) in patients with fixed orthodontic appliances following the application of elmex® gelée

GABA GmbH0 sites314 target enrollmentOctober 25, 2006

Overview

No summary available.

Registry

who.int

Start Date

October 25, 2006

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

GABA GmbH

•\- Treatment plan: minimum of 10 teeth to be bonded labially
•\- At least 10 years old
•\- Highly effectively birth control for girls and women with child\-bearing potential (e. g. implants, oral contraceptives, injectables, plasters, sexual abstinence, vasectomised partner, IUDs)
•\- Written declaration of informed consent
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

•\- Known allergy to one of the components of the test products
•\- Handicapped patients who have difficulties brushing their teeth
•\- Pathological desquamation changes
•\- Known Pregnancy
•\- Breast feeding.
•\- Eating disorders (e.g. bulimia, anorexia nervosa).
•\- Disease that effects dental hard tissue (i.e. severe fluorosis, amelogenesis or dentinogenesis imperfecta)
•\- Participation in another clinical trial either currently or within the last 30 days.