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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Tooth; Lesion, White Spot Lesions	Drug: elmex® gelée; Drug: negative control (placebo)	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	48 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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
Study Start Date :	March 2011
Actual Primary Completion Date :	October 2013
Actual Study Completion Date :	October 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Test; 1.25% fluoride (elmex® gelée)	Drug: elmex® gelée; 1.25% fluoride (elmex® gelée) Dosage: Weekly brushing with 0.5g of respective gel Route: Intraoral topical; Other Name: elmex® gel
Placebo Comparator: Control; 0% fluoride (negative control)	Drug: negative control (placebo); 0% fluoride (negative control) Dosage: Weekly brushing with 0.5g Route: Intraoral topical

Outcome Measures

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Primary Outcome Measures :

1. WSL-size change [ Time Frame: 12 weeks ]
   Changes in size of white spot lesions (WSL) at 12 weeks

Secondary Outcome Measures :

1. WSL-size change [ Time Frame: Baseline up to 24 weeks ]
   Changes in size of WSL over study time
2. WSL-brightness change [ Time Frame: Baseline up to 24 weeks ]
   Changes in WSL brightness value (%)
3. WSL index on all upper front teeth [ Time Frame: 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
4. Caries activity [ Time Frame: Baseline up to 24 weeks ]
   Caries activity index (LAA) according to the ICDAS II (Ekstrand et al. 2007)
5. Plaque index (Silness and Löe 1964)on all upper front teeth [ Time Frame: 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
6. Gingival bleeding index on all upper front teeth [ Time Frame: Baseline up to 24 weeks ]

   Gingival bleeding index (Ainamo and Bay 1975). The following scores will be used:

   (0) no bleeding

   (1) bleeding occurs

7. DMFT index: Dental health of all teeth [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	11 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
Poliklinik für Kieferorthopädie, Justus-Liebig-Universität Giessen
Giessen, Germany, D-35392

Sponsors and Collaborators

Gaba International AG

PD Dr. Christian Heumann

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bock NC, Seibold L, Heumann C, Gnandt E, Röder M, Ruf S. Changes in white spot lesions following post-orthodontic weekly application of 1.25 per cent fluoride gel over 6 months-a randomized placebo-controlled clinical trial. Part II: clinical data evaluation. Eur J Orthod. 2017 Apr 1;39(2):144-152. doi: 10.1093/ejo/cjw061.

Bock NC, Seibold L, Heumann C, Gnandt E, Röder M, Ruf S. Changes in white spot lesions following post-orthodontic weekly application of 1.25 per cent fluoride gel over 6 months-a randomized placebo-controlled clinical trial. Part I: photographic data evaluation. Eur J Orthod. 2017 Apr 1;39(2):134-143. doi: 10.1093/ejo/cjw060.

Responsible Party:	Gaba International AG
ClinicalTrials.gov Identifier:	NCT01329731 History of Changes
Other Study ID Numbers:	GASAS-1002X; 2010-020538-24 ( EudraCT Number )
First Posted:	April 6, 2011
Last Update Posted:	December 11, 2013
Last Verified:	May 2011

Keywords provided by Gaba International AG:

white spot lesion; initial caries; fluoride; amine fluoride	orthodontics; remineralization; brackets

Additional relevant MeSH terms:

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Fluorides	Olaflur; Cariostatic Agents; Protective Agents; Physiological Effects of Drugs