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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005184-29-DE

Enrollment

314

Registered

2006-10-25

Start date

2006-02-21

Completion date

Unknown

Last updated

2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

incipient carious lesions (white spot lesions)

Interventions

Product Name: elmex® gelée Pharmaceutical Form: Dental gel INN or Proposed INN: olaflur CAS Number: 6818-37-7 Concentration unit: g gram(s) Concentration type: equal Concentration number: 30.32 mg- IN

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The once per week application of elmex® gelée plus four times per year tray application is more effective in preventing the formation of white spot lesions in orthodontic patients compared to a test group treated with a non-fluoridated placebo gel. Evaluated on a patient level as time-to event analysis. ;Secondary Objective: 1. The application of elmex® gelée in orthodontic patients leads to a better prevention of white spot lesions than the application of a placebo as measured by QLF. 2. The application of elmex® gelée in orthodontic patients reduces the frequency of WSLs compared to placebo 3. The application of elmex® gelée in orthodontic patients leads in the same time interval to less WSLs as compared to placebo ;Primary end point(s): Primary endpoints Time and frequency of WSLs (white spot lesions) according to the following criteria: 1. Cavitation 2. Any new white spot exceeding 2 mm in any direction 3. New or progressing approximal lesion detectable by bite-wing 4. More than 4 teeth affected with new white spot lesions (in any size)	—

Measure

Time frame

Main Objective: The once per week application of elmex® gelée plus four times per year tray application is more effective in preventing the formation of white spot lesions in orthodontic patients compared to a test group treated with a non-fluoridated placebo gel. Evaluated on a patient level as time-to event analysis. ;Secondary Objective: 1. The application of elmex® gelée in orthodontic patients leads to a better prevention of white spot lesions than the application of a placebo as measured by QLF. 2. The application of elmex® gelée in orthodontic patients reduces the frequency of WSLs compared to placebo 3. The application of elmex® gelée in orthodontic patients leads in the same time interval to less WSLs as compared to placebo ;Primary end point(s): Primary endpoints Time and frequency of WSLs (white spot lesions) according to the following criteria: 1. Cavitation 2. Any new white spot exceeding 2 mm in any direction 3. New or progressing approximal lesion detectable by bite-wing 4. More than 4 teeth affected with new white spot lesions (in any size)

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026