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

Tooth; Lesion, White Spot Lesions Clinical Trial

Official title:

White Spot Lesion Development in Post-orthodontic Patients Following Weekly Application of a 1.25% Fluoride Gel Compared to Placebo Over 6 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329731
• Other study ID #: GASAS-1002X
• Secondary ID: 2010-020538-24
• Status: Completed
• Phase: Phase 4
• First received: April 1, 2011
• Last updated: December 10, 2013
• Start date: March 2011
• Est. completion date: October 2013

Study information

• Verified date: May 2011
• Source: Gaba International AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tooth; Lesion, White Spot Lesions

Intervention

Drug:
• elmex® gelée
1.25% fluoride (elmex® gelée) Dosage: Weekly brushing with 0.5g of respective gel Route: Intraoral topical
• negative control (placebo)
0% fluoride (negative control) Dosage: Weekly brushing with 0.5g Route: Intraoral topical

Locations

Country	Name	City	State
Germany	Poliklinik für Kieferorthopädie, Justus-Liebig-Universität Giessen	Giessen

Sponsors (2)

Lead Sponsor	Collaborator
Gaba International AG	PD Dr. Christian Heumann

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WSL-size change	Changes in size of white spot lesions (WSL) at 12 weeks	12 weeks	No
Secondary	WSL-size change	Changes in size of WSL over study time	Baseline up to 24 weeks	No
Secondary	WSL-brightness change	Changes in WSL brightness value (%)	Baseline up to 24 weeks	No
Secondary	WSL index on all upper front teeth	Modified white spot lesion index (Gorelick et al. 1982): 0: no white spot formation; slight white spot formation, thin rim; excessive white spot formation, thicker bands; white spot formation with cavitation	Baseline up to 24 weeks	No
Secondary	Caries activity	Caries activity index (LAA) according to the ICDAS II (Ekstrand et al. 2007)	Baseline up to 24 weeks	No
Secondary	Plaque index (Silness and Löe 1964)on all upper front teeth	The grades will be assessed visually on all upper front teeth using a standard dental probe.; (0) no plaque on inspection and probing; thin plaque film on gingival margin, detectable only on probing; moderate plaque film along the gingival margin, visually detectable even without probing; a lot of plaque along the gingival margin, filling the interdental spaces	Baseline up to 24 weeks	No
Secondary	Gingival bleeding index on all upper front teeth	Gingival bleeding index (Ainamo and Bay 1975). The following scores will be used: (0) no bleeding; (1) bleeding occurs	Baseline up to 24 weeks	No
Secondary	DMFT index: Dental health of all teeth	DMFT index according to Klein et al. (1938): Dental health of all teeth will be assessed with respect to decay (D), missing (M) or filling (F). The DMFT-Index will be calculated.	Baseline, 24 weeks	No