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NCT01950988 Clinical Trial

Effectiveness of a Novel Concept for a Manual Toothbrush Broscyl®

Healthy Subjects Clinical Trial

— BROSCYL  

Official title:
Effectiveness and Satisfaction-adaptability of a Novel Concept for a Manual Toothbrush Broscyl®: Randomised Clinical Trial in Children, Adults and Elderly People

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01950988
Other study ID # ZWETYENGA PHRC IR 2011
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 16, 2013
Est. completion date June 8, 2016

Study information
Verified date February 2024
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim is to determine the efficacy and the satisfaction/adaptability of the manual Broscyl® toothbrush as compared with a standard " soft " manual toothbrush ADA (American Dental Association) reference using the modified Stillman brushing technique, in children, adults and elderly persons, after 3 months of daily use.

Recruitment information / eligibility
Status Terminated
Enrollment 142
Est. completion date June 8, 2016
Est. primary completion date June 8, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years and older
Eligibility Inclusion Criteria: - Children attending school aged between 8 and 15 years - OR adults aged from 18 to 45 years - OR elderly persons aged more than 65 years old - Presenting at least one incisive, one canine, one premolar and one molar in each quadrant - Able to brush their own teeth at least twice a day - Persons who have provided written informed consent - Persons covered by the national health insurance agency Exclusion Criteria: - Persons with acute periodontal disease - Persons in a period of postsurgical healing - Persons with an acute oral pain syndrome - Persons undergoing orthodontic treatment with a fixed brace - Persons not covered by the national health insurance agency - Pregnant women - The use of adjuvants

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Manual toothbrush reference

Procedure:
• Measure of the dental plaque

Device:
• Manual toothbrush Broscyl®

Locations
Country Name City State
France CHU Dijon Dijon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measurement of the dental plaque index up to 3 months
Secondary Patient satisfaction self-completed questionnaire up to 3 months
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