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Effectiveness of a Novel Concept for a Manual Toothbrush Broscyl® (BROSCYL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01950988
Recruitment Status : Unknown
Verified September 2013 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : September 26, 2013
Last Update Posted : September 26, 2013
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Device: Manual toothbrush reference Procedure: Measure of the dental plaque Device: Manual toothbrush Broscyl® Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: Effectiveness and Satisfaction-adaptability of a Novel Concept for a Manual Toothbrush Broscyl®: Randomised Clinical Trial in Children, Adults and Elderly People
Study Start Date : July 2013
Estimated Primary Completion Date : July 2015

Arm Intervention/treatment
Children Device: Manual toothbrush reference
Procedure: Measure of the dental plaque
Device: Manual toothbrush Broscyl®
Adults Device: Manual toothbrush reference
Procedure: Measure of the dental plaque
Device: Manual toothbrush Broscyl®
Elderly people Device: Manual toothbrush reference
Procedure: Measure of the dental plaque
Device: Manual toothbrush Broscyl®



Primary Outcome Measures :
  1. Measurement of the dental plaque index [ Time Frame: up to 3 months ]

Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: up to 3 months ]
    self-completed questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950988


Contacts
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Contact: Narcisse ZWETYENGA 03.80.29.37. 57 narcisse.zwetyenga@chu-dijon.fr

Locations
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France
CHU Dijon Recruiting
Dijon, France, 21000
Contact: Narcisse ZWETYENGA    03.80.29.37. 57    narcisse.zwetyenga@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01950988    
Other Study ID Numbers: ZWETYENGA PHRC IR 2011
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: September 26, 2013
Last Verified: September 2013