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A clinical evaluation comparing a power Toothbrush with Smartphone application to manual Toothbrush among adolescents with fixed orthodontic Appliances

Laufzeit: 01.01.2015 - 31.12.2019

Kurzfassung


This is a single-center, examiner-blind, 6 week, 2 treatment, parallel group, randomized study design. Approximately sixty (60) adolescent subjects, 13-17 years of age, who show evidence of areas with dental plaque and who are routine manual toothbrush users and possess a Smartphone will be enrolled in this study. Plaque measurements will be taken at four time points: Screening, Baseline, Week 2, and Week 6 using the Turesky Modified Quigley-Hein Plaque Index (TQHPI).
Subjects will be asked to...
This is a single-center, examiner-blind, 6 week, 2 treatment, parallel group, randomized study design. Approximately sixty (60) adolescent subjects, 13-17 years of age, who show evidence of areas with dental plaque and who are routine manual toothbrush users and possess a Smartphone will be enrolled in this study. Plaque measurements will be taken at four time points: Screening, Baseline, Week 2, and Week 6 using the Turesky Modified Quigley-Hein Plaque Index (TQHPI).
Subjects will be asked to refrain from all oral hygiene procedures after their morning brushing (which is to be no later than 8 am) prior to all visits (Screening, Baseline, Week 2, and Week 6). In addition, the subjects will be asked to refrain from eating, drinking, or chewing gum for 2 hours prior to their appointment time. Only small sips of water are permissible. Subjects should refrain from sipping water 45 minutes prior to their scheduled visit.
Subjects will complete a pre and post-use questionnaire with elements of self-assessment (brushing habits, compliance, oral care motivation, self-perceived change in oral health). The subject post-use questionnaire will also include elements of user satisfaction. Specific procedures are detailed below (Table 1).
 
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