Remineralisation of White Spot Lesions by Elmex® gelée in Post-orthodontic Patients

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to monitor the effect of intraoral topical high fluoride application on the development of white spot lesions (WSL) after orthodontic treatment with multibracket appliances and to compare it to a placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gaba International AG
• Collaborator: PD Dr. Christian Heumann
• Treatments: Fluorides; Olaflur

Criteria

Inclusion Criteria:

• Written informed consent

• Healthy volunteers (≥11 years) scheduled for bracket removal

• ≥ 1 WSL with a modified score 1 or 2 (Gorelick et al. 1982) on UFT at debonding

Exclusion Criteria:

• Known hypersensitivity or allergy to study products and standard toothpaste ingredients and/or dental material used in the present study

• Known hypersensitivity or allergy to placebo gel ingredients

• Alterations in the teeth's enamel, e.g. hypoplasia, fluorosis

• Any illness/condition potentially affecting the study outcome at investigator's discretion

• Known pregnancy or breast feeding during the course of the study