- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00877019
Time Dependent Professional Toothbrushing Study (timebrush)
Time Dependent Professional Toothbrushing Study Comparing Sonicare With Manual Toothbrushes
Aim:
The study was designed to test the time dependent efficacy in plaque removal of four toothbrushes: one electric toothbrush, the Philips Sonicare Elite with long (A) and short (B) brushing head and two manual brushes, the Gaba Sensitve (C), and the ADA reference brush (D) and.
Materials and Methods:
The study was a single-blind, randomized clinical timer study consisting of four identical experiments testing each brush in one quadrant. The distribution of the quadrants and brushes was randomized so that always all brushes were used within one participant. The teeth were brushed by a dental hygienist for 10, 20, 30, 45, 60 und 90 seconds per quadrant. No toothpaste was used throughout this study. The plaque assessment (Tureskey modified QHI) was done after each time interval blinded on six sites per tooth by a separate investigator. Ninety subjects participated in the study and received a professional prophylaxis prior to the experiment. They were requested to refrain from brushing their teeth for 48 hours prior to the experiment.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- at least 24 evaluable teeth in the mouth
Exclusion Criteria:
- systemic disease
- regular drugs or actual antibiotics
- orthodontic banding or retention wires
- oral lesions or sites with a probing pocket depth X5 mm
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Masking: SINGLE
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 001 (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES))
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