Effectiveness of a Novel Concept for a Manual Toothbrush Broscyl® (BROSCYL)
February 26, 2024 updated by: Centre Hospitalier Universitaire Dijon
Effectiveness and Satisfaction-adaptability of a Novel Concept for a Manual Toothbrush Broscyl®: Randomised Clinical Trial in Children, Adults and Elderly People
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
142
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Dijon, France, 21000
- CHU Dijon
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Children
|
|
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Other: Adults
|
|
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Other: Elderly people
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Measurement of the dental plaque index
Time Frame: up to 3 months
|
up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction
Time Frame: up to 3 months
|
self-completed questionnaire
|
up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 16, 2013
Primary Completion (Actual)
June 8, 2016
Study Completion (Actual)
June 8, 2016
Study Registration Dates
First Submitted
August 27, 2013
First Submitted That Met QC Criteria
September 25, 2013
First Posted (Estimated)
September 26, 2013
Study Record Updates
Last Update Posted (Actual)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 26, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- ZWETYENGA PHRC IR 2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.