Effectiveness of a Novel Concept for a Manual Toothbrush Broscyl®

Not Applicable

Terminated

• Conditions: Healthy Subjects
• Interventions: Device: Manual toothbrush reference; Procedure: Measure of the dental plaque; Device: Manual toothbrush Broscyl®

• Registration Number: NCT01950988
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-16
• Study First Submitted: 2013-08-27
• Study First Submitted QC: 2013-09-25
• Study First Posted: 2013-09-26
• Primary Completion: 2016-06-08
• Study Completion: 2016-06-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 142

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Children	Measure of the dental plaque	-
Children	Manual toothbrush Broscyl®	-
Children	Manual toothbrush reference	-
Elderly people	Manual toothbrush reference	-
Elderly people	Measure of the dental plaque	-
Adults	Manual toothbrush reference	-
Adults	Measure of the dental plaque	-
Adults	Manual toothbrush Broscyl®	-
Elderly people	Manual toothbrush Broscyl®	-

Primary Outcome Measures

Name	Time	Method
Measurement of the dental plaque index	up to 3 months

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	up to 3 months	self-completed questionnaire

Trial Locations

Locations (1)

CHU Dijon; 🇫🇷 Dijon, France