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

December 10, 2013 updated by: Gaba International AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WSL-size change
Time Frame: 12 weeks
Changes in size of white spot lesions (WSL) at 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WSL-size change
Time Frame: Baseline up to 24 weeks
Changes in size of WSL over study time
Baseline up to 24 weeks
WSL-brightness change
Time Frame: Baseline up to 24 weeks
Changes in WSL brightness value (%)
Baseline up to 24 weeks
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
Baseline up to 24 weeks
Caries activity
Time Frame: Baseline up to 24 weeks
Caries activity index (LAA) according to the ICDAS II (Ekstrand et al. 2007)
Baseline up to 24 weeks
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
Baseline up to 24 weeks
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
Baseline up to 24 weeks
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.
Baseline, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaba International AG

Collaborators

PD Dr. Christian Heumann

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

April 1, 2011

First Submitted That Met QC Criteria

April 5, 2011

First Posted (Estimate)

April 6, 2011

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GASAS-1002X
  • 2010-020538-24 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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