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

NCT ID: NCT01329731

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-10-31

Brief Summary

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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

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Conditions

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Tooth; Lesion, White Spot Lesions

Keywords

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white spot lesion initial caries fluoride amine fluoride orthodontics remineralization brackets

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Test

1.25% fluoride (elmex® gelée)

Group Type ACTIVE_COMPARATOR

elmex® gelée

Intervention Type DRUG

1.25% fluoride (elmex® gelée) Dosage: Weekly brushing with 0.5g of respective gel Route: Intraoral topical

Control

0% fluoride (negative control)

Group Type PLACEBO_COMPARATOR

negative control (placebo)

Intervention Type DRUG

0% fluoride (negative control) Dosage: Weekly brushing with 0.5g Route: Intraoral topical

Interventions

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elmex® gelée

1.25% fluoride (elmex® gelée) Dosage: Weekly brushing with 0.5g of respective gel Route: Intraoral topical

Intervention Type DRUG

negative control (placebo)

0% fluoride (negative control) Dosage: Weekly brushing with 0.5g Route: Intraoral topical

Intervention Type DRUG

Other Intervention Names

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elmex® gel

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PD Dr. Christian Heumann

UNKNOWN

Sponsor Role collaborator

Gaba International AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Poliklinik für Kieferorthopädie, Justus-Liebig-Universität Giessen

Giessen, , Germany

Site Status

Countries

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Germany

References

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Bock NC, Seibold L, Heumann C, Gnandt E, Roder 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.

Reference Type DERIVED
PMID: 27702807 (View on PubMed)

Bock NC, Seibold L, Heumann C, Gnandt E, Roder 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.

Reference Type DERIVED
PMID: 27702806 (View on PubMed)

Other Identifiers

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2010-020538-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GASAS-1002X

Identifier Type: -

Identifier Source: org_study_id