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Study to assess the status of oral health before and in the first 6 months of an orthodontic treatment

Laufzeit: 01.01.2013 - 31.12.2017

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Kurzfassung


MAIFOR
Study Objective:
The main objective of this study is to assess the status of oral health before and in the first 6 months of an orthodontic treatment using the Turesky Modification of the Quigley-Hein Plaque Index (TMQH) and Digital Image Analysis System (DPIA) for plaque, the Quantitative Light-induced Fluorescense (QLF) for detection and progression of White Spot Lesions, the Löe-Silness Index (GI) for gingivitis and the White Spot Lesions Index (WSL) for decalcification.
The second...
MAIFOR
Study Objective:
The main objective of this study is to assess the status of oral health before and in the first 6 months of an orthodontic treatment using the Turesky Modification of the Quigley-Hein Plaque Index (TMQH) and Digital Image Analysis System (DPIA) for plaque, the Quantitative Light-induced Fluorescense (QLF) for detection and progression of White Spot Lesions, the Löe-Silness Index (GI) for gingivitis and the White Spot Lesions Index (WSL) for decalcification.
The second objective of this clinical trial is to evaluate the association between oral fluid biomarkers with gingival conditions such as mild to moderate gingivitis and gingival health using Saliva and Gingival Crevicular Fluid samples for biomarkers/metabonomics.
The third objective of the study is to evaluate the treatment outcome acceptability and the degree of improvement using the Index of Complexity, Outcome and Need (ICON) and a questionnaire reflecting the quality of life regarding tooth aesthetics.
Overall Study Design and Plan — Description
Overview:
This is a controlled, examiner-blind, single-treatment study with 5 study visits.  Up to 100 subjects with no history of orthodontic treatment will be enrolled into the study. 
Overnight plaque accumulation will be measured by digital plaque image analysis of fluorescein-disclosed plaque and also evaluated by means of the modified Quigley Hein Plaque Index at each visit except the day of bonding the brackets. GCF samples will be collected at Baseline (Screening), 3 weeks, 3 months and 6 months after bracket bonding. GI will be assessed at the same time points as the GCF collection.
Saliva samples will be collected at home during weeks prior study visits and brought to the study site for Metabonomics analysis.
QLF and WSL will be assessed at Baseline (Screening) and after 6 months.
The Index of Complexity, Outcome and Need (ICON) and a questionnaire about the quality of life during orthodontic treatment will be assessed at Baseline (Screening) and after 6 months.
 
 
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