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

Gaba International

Status and phase: Completed; Phase 4

Conditions: Tooth; Lesion, White Spot Lesions

Treatments: Drug: elmex® gelée; Drug: negative control (placebo)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01329731

GASAS-1002X

2010-020538-24 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 11+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

48 participants in 2 patient groups, including a placebo group

Test

Active Comparator group

Description:

1.25% fluoride (elmex® gelée)

Treatment:

Drug: elmex® gelée

Control

Placebo Comparator group

Description:

0% fluoride (negative control)

Treatment:

Drug: negative control (placebo)