Study evaluating the oral hygiene status and quality of life of the patient before, during and after the Aligner-Therapy (Invisalign®)
Laufzeit: 01.01.2014 - 31.12.2019
Kurzfassung
The German Oral Health Study IV (DMS IV) from 2005 shows that for 45% of children (age: 12 years) and 58% of adolescents (age: 15 years) an orthodontic treatment has either been carried out or was planned. In addition, a clear decline in the incidence of caries in children and teenagers was reported. 70.1% of the children (age: 12 years) and 46.1% of teenagers (age: 15 years) had caries-free teeth. Nearly 80% of caries cases were experienced by only 26.5% of the teenagers (age: 15 years)...The German Oral Health Study IV (DMS IV) from 2005 shows that for 45% of children (age: 12 years) and 58% of adolescents (age: 15 years) an orthodontic treatment has either been carried out or was planned. In addition, a clear decline in the incidence of caries in children and teenagers was reported. 70.1% of the children (age: 12 years) and 46.1% of teenagers (age: 15 years) had caries-free teeth. Nearly 80% of caries cases were experienced by only 26.5% of the teenagers (age: 15 years) (Brauckhoff et al. 2009) [1]. In the overall patient population of the Department of Orthodontics at the Medical University of Mainz, about 80% of patients are treated with fixed orthodontic appliances. Aligner Therapy is also a contemporary procedure for orthodontic treatment. In 2011, approximately 78.000 patients worldwide were treated by Invisalign teen. Dental plaque plays an important role in the development of caries and oral disease. Plaque removal and control are important aspects of oral health establishment and maintenance (Shibly et al., 1995)[2]. Plaque can cause dental demineralisation (WSL - White Spot Lesions), a prerequisite for the onset of caries, and lead to gingivitis (Gorelick et al., 1982, Oogaard B, 1989, Årtun and Brobakken, 1986) [3-5]. Therefore, the main objective of this proposed controlled clinical trial is to assess the quantity of WSL between an aligner treatment group (Invisalign teen) and a control group wearing fixed orthodontic appliances. This study is designed as a prospective, controlled, single-treatment study with 7 study visits. Up to 50 subjects with no history of orthodontic treatment will be enrolled into the study. Subjects who meet the inclusion and exclusion criteria will receive a comprehensive oral examination (OST) to evaluate the oral and perioral region, including hard and soft tissues. Overnight plaque accumulation will be evaluated by means of the modified Quigley Hein Plaque Index (TMQH) at each visit. Gingival Crevicular Fluid (GCF) samples will be collected at Baseline (Screening), 4 weeks, 6 months, 1 year and 1 ½ year after receiving first aligner, 3 months after aligner therapy and 1 year after finishing the aligner therapy. Gingivitis-Index (GI) will be assessed at the same time points as the GCF collection. Quantitative Light Induced Fluorescence (QLF) and White Spot Lesion-Index (WSL) will be assessed at visit 1, 6 months, 1 year and 1 ½ year after receiving first aligner, 3 months after aligner therapy and 1 year after finishing the aligner therapy.
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