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

• Conditions: incipient carious lesions (white spot lesions)

• Registration Number: EUCTR2005-005184-29-DE
• Lead Sponsor: GABA GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-25
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 314

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified