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Completed

NCT Number: NCT01329731

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

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.

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Key information

Conditions

Tooth; Lesion, White Spot Lesions

Age range

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Poliklinik für Kieferorthopädie, Justus-Liebig-Universität Giessen

Giessen, D-35392, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

elmex® gelée

Drug

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

Other names: elmex® gel

negative control (placebo)

Drug

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

Primary outcomes

  1. WSL-size change

    Time frame: 12 weeks

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

Secondary outcomes

  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

    • slight white spot formation, thin rim
    • excessive white spot formation, thicker bands
    • 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

    • thin plaque film on gingival margin, detectable only on probing
    • moderate plaque film along the gingival margin, visually detectable even without probing
    • 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.

Sponsors and collaborators

Lead sponsor

Gaba International AG

Industry

Collaborators

  • PD Dr. Christian Heumann

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 6, 2011
Registry last updated
Dec 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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