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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020538-24 | EudraCT Number |
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| Name | Class |
|---|---|
| PD Dr. Christian Heumann | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Active Comparator | 1.25% fluoride (elmex® gelée) |
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| Control | Placebo Comparator | 0% fluoride (negative control) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| elmex® gelée | Drug | 1.25% fluoride (elmex® gelée) Dosage: Weekly brushing with 0.5g of respective gel Route: Intraoral topical |
|
| Measure | Description | Time Frame |
|---|---|---|
| WSL-size change | Changes in size of white spot lesions (WSL) at 12 weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| WSL-size change | Changes in size of WSL over study time | Baseline up to 24 weeks |
| WSL-brightness change | Changes in WSL brightness value (%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poliklinik für Kieferorthopädie, Justus-Liebig-Universität Giessen | Giessen | D-35392 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27702807 | Derived | Bock NC, Seibold L, Heumann C, Gnandt E, Roder M, Ruf S. Changes in white spot lesions following post-orthodontic weekly application of 1.25 per cent fluoride gel over 6 months-a randomized placebo-controlled clinical trial. Part II: clinical data evaluation. Eur J Orthod. 2017 Apr 1;39(2):144-152. doi: 10.1093/ejo/cjw061. | |
| 27702806 |
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| negative control (placebo) | Drug | 0% fluoride (negative control) Dosage: Weekly brushing with 0.5g Route: Intraoral topical |
|
| Baseline up to 24 weeks |
| WSL index on all upper front teeth | Modified white spot lesion index (Gorelick et al. 1982): 0: no white spot formation
| Baseline up to 24 weeks |
| Caries activity | Caries activity index (LAA) according to the ICDAS II (Ekstrand et al. 2007) | Baseline up to 24 weeks |
| Plaque index (Silness and Löe 1964)on all upper front teeth | The grades will be assessed visually on all upper front teeth using a standard dental probe. (0) no plaque on inspection and probing
| Baseline up to 24 weeks |
| Gingival bleeding index on all upper front teeth | Gingival bleeding index (Ainamo and Bay 1975). The following scores will be used: (0) no bleeding (1) bleeding occurs | Baseline up to 24 weeks |
| DMFT index: Dental health of all teeth | 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. | Baseline, 24 weeks |
| Bock NC, Seibold L, Heumann C, Gnandt E, Roder M, Ruf S. Changes in white spot lesions following post-orthodontic weekly application of 1.25 per cent fluoride gel over 6 months-a randomized placebo-controlled clinical trial. Part I: photographic data evaluation. Eur J Orthod. 2017 Apr 1;39(2):134-143. doi: 10.1093/ejo/cjw060. |