Remineralisation of White Spot Lesions by Elmex® gelée in Post-orthodontic Patients
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ClinicalTrials.gov Identifier: NCT01329731 |
Recruitment Status :
Completed
First Posted : April 6, 2011
Last Update Posted : December 11, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tooth; Lesion, White Spot Lesions | Drug: elmex® gelée Drug: negative control (placebo) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
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 |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | October 2013 |
Actual Study Completion Date : | October 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Test
1.25% fluoride (elmex® gelée)
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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 |
- WSL-size change [ Time Frame: 12 weeks ]Changes in size of white spot lesions (WSL) at 12 weeks
- 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.

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Ages Eligible for Study: | 11 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329731
Germany | |
Poliklinik für Kieferorthopädie, Justus-Liebig-Universität Giessen | |
Giessen, Germany, D-35392 |
Responsible Party: | Gaba International AG |
ClinicalTrials.gov Identifier: | NCT01329731 |
Other Study ID Numbers: |
GASAS-1002X 2010-020538-24 ( EudraCT Number ) |
First Posted: | April 6, 2011 Key Record Dates |
Last Update Posted: | December 11, 2013 |
Last Verified: | May 2011 |
white spot lesion initial caries fluoride amine fluoride |
orthodontics remineralization brackets |
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases |
Olaflur Cariostatic Agents Protective Agents Physiological Effects of Drugs |