The purpose of this study is to assess the plaque removal efficacy of three experimental manual toothbrushes relative to a regular manual toothbrush using the Turesky Modified Quigley-Hein Plaque Index (TQHPI)
Laufzeit: 01.01.2016 - 31.12.2022
Kurzfassung
Overall Study Design and Plan
This is a replicate use single brushing, four-treatment, examiner-blind, randomized, eight period, crossover design. Approximately 20 adult subjects at least 18 years of age, will be enrolled into the clinical trial based on study criteria. Subjects will be instructed to refrain from all oral hygiene procedures for approximately 12 hours prior to their appointments. In addition, the subjects will be instructed to refrain from eating, drinking, chewing gum or...Overall Study Design and Plan
This is a replicate use single brushing, four-treatment, examiner-blind, randomized, eight period, crossover design. Approximately 20 adult subjects at least 18 years of age, will be enrolled into the clinical trial based on study criteria. Subjects will be instructed to refrain from all oral hygiene procedures for approximately 12 hours prior to their appointments. In addition, the subjects will be instructed to refrain from eating, drinking, chewing gum or smoking (including smokeless tobacco) for 4 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.
Inclusion Criteria
In order to be included in the study, each subject must:
-provide written informed consent and receive a signed copy;
-be at least 18 years of age and mainly use a manual toothbrush;
-be in good general health as determined by the investigator/designee based on a review/update of their medical history;
-have a whole mouth average pre-brushing TQHPI score of ³1.75 at Period-1;
-possess a minimum of 16 scorable teeth with facial and lingual scorable surfaces;
-refrain from all oral hygiene procedures for approximately 12 hours prior to this visit and agree to follow this same restriction prior to all visits;
-refrain from eating, drinking (except small sips of water up until 45 minutes prior to their appointment), chewing gum and using tobacco for at least 4 hours prior to this visit and agree to follow these same restrictions prior to all visits;
-agree not to participate in any other oral care study for the duration of this study;
-agree to delay any elective dentistry, including dental prophylaxis, until study completion and to report any non-study dentistry received during the course of this study;
-agree to refrain from using any non-study toothbrushes, dentifrices, mouth rinses, tooth whitening products or floss for the study duration other than their regular at-home toothbrush and toothpaste used between visits;
-agree to maintain their same regular at-home toothbrush and toothpaste for the study duration;
-agree to return for their scheduled visits and to follow all study procedures.Exclusion Criteria
Subjects are excluded from study participation where there is evidence of:
-Any carious lesions requiring restorative treatment;
-active treatment for periodontitis;
-active orthodontic therapy, and/or have removable denture prosthesis;
-any disease or conditions that could be expected to interfere with examination procedures or with the subject safely completing the study (including allergies to dyes);
-dental prophylaxis any time within the 4 weeks prior of the first visit;
-peri/oral piercings;
-using any antibiotics or a chlorhexidine mouth rinse any time within the 2 weeks prior to this visit.
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