Elmex Gel Efficacy in Preventing White Spot Lesions

Phase 4 Study Prevention of Incipient Carious Lesions (White Spot Lesions) in Patients With Fixed Orthodontic Appliances Following the Application of Elmex Gel

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00268138

Enrollment

314

Registered

2005-12-22

Start date

2006-04-30

Completion date

2010-12-31

Last updated

2009-02-18

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

Conditions

Dental Caries

Keywords

amine fluoride, white spot lesions, qlf

Brief summary

the objective of this phase IV study: to establish the efficacy of elmex gel with a fluoride concentration of 1.25% compared with placebo by determining prevention of white spot lesions in patients wearing fixed orthodontic appliances.

Detailed description

314 healthy subjects undergoing orthodontic treatment will be examined. follow up will take place from bonding the appliance till debonding, at least 12 months and no more than 30 months. tooth brushing with product (test product or control) once per week during the entire study. 4 times a year additional tray application of test product or control. subjects wiil clean their teeth with the toothpaste they usually use during the entire study. toothbrush and a sandglass will be provided every 6 weeks

Interventions

DRUGelmex gel

elmex gel once a week

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

10 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* treatment plan: minimum of 10 teeth to be bonded labially at least 10 years old * written declaration of informed consent

Exclusion criteria

* known allergy to components of test products * handicapped patients who have difficulties brushing their teeth * pathological desquamation changes * known pregnancy, breast feeding * eating disorders * disease that effect dental hard tissue * participation in another clinical trial either currently or within the lase 30 days

Design outcomes

Primary

Measure	Time frame
time and frequency of visually detected WSL (white spot lesions)	3 month

Secondary

Measure	Time frame
Frequency and chronoloy of WSL	3 month
mineral loss according to QLF readings	3 month

Countries

Germany, Israel

Contacts

Primary ContactAndrea Engl, Dr.

a.engl@gaba.com++41614156056

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026