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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Gaba International AG

Current Primary Outcome: WSL-size change [ Time Frame: 12 weeks ]

Changes in size of white spot lesions (WSL) at 12 weeks


Original Primary Outcome: 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, %)


Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • 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.


Information By: Gaba International AG

Dates:
Date Received: April 1, 2011
Date Started: March 2011
Date Completion:
Last Updated: December 10, 2013
Last Verified: May 2011