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

This study has been completed.
Sponsor:
Collaborator:
PD Dr. Christian Heumann
Information provided by (Responsible Party):
Gaba International AG
ClinicalTrials.gov Identifier:
NCT01329731
First received: April 1, 2011
Last updated: December 10, 2013
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Tooth; Lesion, White Spot Lesions
Drug: elmex® gelée
Drug: negative control (placebo)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gaba International AG:

Primary Outcome Measures:
  • WSL-size change [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Changes in size of white spot lesions (WSL) at 12 weeks


Secondary Outcome Measures:
  • WSL-size change [ Time Frame: Baseline up to 24 weeks ] [ Designated as safety issue: No ]
    Changes in size of WSL over study time

  • WSL-brightness change [ Time Frame: Baseline up to 24 weeks ] [ Designated as safety issue: No ]
    Changes in WSL brightness value (%)

  • WSL index on all upper front teeth [ Time Frame: Baseline up to 24 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 48
Study Start Date: March 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   11 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329731

Locations
Germany
Poliklinik für Kieferorthopädie, Justus-Liebig-Universität Giessen
Giessen, Germany, D-35392
Sponsors and Collaborators
Gaba International AG
PD Dr. Christian Heumann
  More Information

No publications provided

Responsible Party: Gaba International AG
ClinicalTrials.gov Identifier: NCT01329731     History of Changes
Other Study ID Numbers: GASAS-1002X, 2010-020538-24
Study First Received: April 1, 2011
Last Updated: December 10, 2013
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Gaba International AG:
white spot lesion
initial caries
fluoride
amine fluoride
orthodontics
remineralization
brackets

Additional relevant MeSH terms:
Exanthema
Dental Caries
Skin Diseases
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Olaflur
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014