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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01329731
First Posted: April 6, 2011
Last Update Posted: December 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
PD Dr. Christian Heumann
Information provided by (Responsible Party):
Gaba International AG
April 1, 2011
April 6, 2011
December 11, 2013
March 2011
October 2013   (Final data collection date for primary outcome measure)
WSL-size change [ Time Frame: 12 weeks ]
Changes in size of white spot lesions (WSL) at 12 weeks
WSL-size change [ Time Frame: 12 weeks ]
Changes in size of white spot lesions (WSL) at 12 weeks (lesion size to total labial tooth area, %)
Complete list of historical versions of study NCT01329731 on ClinicalTrials.gov Archive Site
  • WSL-size change [ Time Frame: Baseline up to 24 weeks ]
    Changes in size of WSL over study time
  • WSL-brightness change [ Time Frame: Baseline up to 24 weeks ]
    Changes in WSL brightness value (%)
  • 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
  • Caries activity [ Time Frame: 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 [ 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
  • 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

  • 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.
  • WSL-size change [ Time Frame: 1, 2, 6, 12, 24 weeks ]
    Changes in size of WSL over study time
  • WSL-brightness change [ Time Frame: 1, 2, 6, 12, 24 weeks ]
    Changes in the mean pixel brightness value of WSL (%)
  • WSL index on all upper front teeth [ Time Frame: 1, 2, 6, 12, 24 weeks ]

    Modified white spot lesion index (Gorelick et al. 1982): teeth are dried with compressed air for 10 seconds and the labial surface is visually examined using the following scores:

    (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 [ Time Frame: 1, 2, 6, 12, 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 [ Time Frame: 1, 2, 6, 12, 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 [ Time Frame: 1, 2, 6, 12, 24 weeks ]

    Gingival bleeding index (Ainamo and Bay 1975): The gingiva of all upper front teeth will be air-dried for 10 seconds and a blunt periodontal probe PCP11 with a diameter of 0.5mm will be inserted into the gingival crevice with slight pressure and parallel to the long axis of the tooth, then the probe will be moved along the crevice. The following scores will be used:

    (0) no bleeding

    (1) bleeding occurs

  • DMFT index: Dental health of all teeth [ Time Frame: 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.
Not Provided
Not Provided
 
Remineralisation of White Spot Lesions by Elmex® gelée in Post-orthodontic Patients
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Tooth; Lesion, White Spot Lesions
  • Drug: elmex® gelée
    1.25% fluoride (elmex® gelée) Dosage: Weekly brushing with 0.5g of respective gel Route: Intraoral topical
    Other Name: elmex® gel
  • Drug: negative control (placebo)
    0% fluoride (negative control) Dosage: Weekly brushing with 0.5g Route: Intraoral topical
  • Active Comparator: Test
    1.25% fluoride (elmex® gelée)
    Intervention: Drug: elmex® gelée
  • Placebo Comparator: Control
    0% fluoride (negative control)
    Intervention: Drug: negative control (placebo)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
October 2013
October 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
11 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01329731
GASAS-1002X
2010-020538-24 ( EudraCT Number )
Yes
Not Provided
Not Provided
Gaba International AG
Gaba International AG
PD Dr. Christian Heumann
Not Provided
Gaba International AG
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP