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

Phase 4

Completed

• Conditions: Tooth; Lesion, White Spot Lesions
• Interventions: Drug: negative control (placebo); Drug: elmex® gelée

• Registration Number: NCT01329731
• Lead Sponsor: Gaba International AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-06
• Status Verified: 2011-05
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-12-10
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	negative control (placebo)	0% fluoride (negative control)
Test	elmex® gelée	1.25% fluoride (elmex® gelée)

Primary Outcome Measures

Name	Time	Method
WSL-size change	12 weeks	Changes in size of white spot lesions (WSL) at 12 weeks

Secondary Outcome Measures

Name	Time	Method
WSL-size change	Baseline up to 24 weeks	Changes in size of WSL over study time
WSL-brightness change	Baseline up to 24 weeks	Changes in WSL brightness value (%)
WSL index on all upper front teeth	Baseline up to 24 weeks	Modified white spot lesion index (Gorelick et al. 1982): 0: no white spot formation; 1. slight white spot formation, thin rim; 2. excessive white spot formation, thicker bands; 3. white spot formation with cavitation
Caries activity	Baseline up to 24 weeks	Caries activity index (LAA) according to the ICDAS II (Ekstrand et al. 2007)
Plaque index (Silness and Löe 1964)on all upper front teeth	Baseline up to 24 weeks	The grades will be assessed visually on all upper front teeth using a standard dental probe.; (0) no plaque on inspection and probing; 1. thin plaque film on gingival margin, detectable only on probing; 2. moderate plaque film along the gingival margin, visually detectable even without probing; 3. a lot of plaque along the gingival margin, filling the interdental spaces
Gingival bleeding index on all upper front teeth	Baseline up to 24 weeks	Gingival bleeding index (Ainamo and Bay 1975). The following scores will be used: (0) no bleeding; (1) bleeding occurs
DMFT index: Dental health of all teeth	Baseline, 24 weeks	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.

Trial Locations

Locations (1)

Poliklinik für Kieferorthopädie, Justus-Liebig-Universität Giessen; 🇩🇪 Giessen, Germany