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Remineralisation of White Spot Lesions by Elmex® gelée in Post-orthodontic Patients
This study has been completed.
Sponsor:
Gaba International AG
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
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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 Intervention Model: Parallel Assignment Masking: Double (Participant, 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 ]Changes in size of white spot lesions (WSL) at 12 weeks
Secondary Outcome Measures:
- 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
- slight white spot formation, thin rim
- excessive white spot formation, thicker bands
- 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
- 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
- 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.
| 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 (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01329731
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
| Responsible Party: | Gaba International AG |
| ClinicalTrials.gov Identifier: | NCT01329731 History of Changes |
| Other Study ID Numbers: |
GASAS-1002X 2010-020538-24 ( EudraCT Number ) |
| Study First Received: | April 1, 2011 |
| Last Updated: | December 10, 2013 |
Keywords provided by Gaba International AG:
|
white spot lesion initial caries fluoride amine fluoride |
orthodontics remineralization brackets |
Additional relevant MeSH terms:
|
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases Fluorides |
Olaflur Cariostatic Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on August 21, 2017