Effectiveness of a Novel Concept for a Manual Toothbrush Broscyl®

NCT ID: NCT01950988

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-16

Study Completion Date

2016-06-08

Brief Summary

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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

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Study Groups

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Children

Group Type OTHER

Manual toothbrush reference

Intervention Type DEVICE

Measure of the dental plaque

Intervention Type PROCEDURE

Manual toothbrush Broscyl®

Intervention Type DEVICE

Adults

Group Type OTHER

Manual toothbrush reference

Intervention Type DEVICE

Measure of the dental plaque

Intervention Type PROCEDURE

Manual toothbrush Broscyl®

Intervention Type DEVICE

Elderly people

Group Type OTHER

Manual toothbrush reference

Intervention Type DEVICE

Measure of the dental plaque

Intervention Type PROCEDURE

Manual toothbrush Broscyl®

Intervention Type DEVICE

Interventions

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Manual toothbrush reference

Intervention Type DEVICE

Measure of the dental plaque

Intervention Type PROCEDURE

Manual toothbrush Broscyl®

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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ZWETYENGA PHRC IR 2011

Identifier Type: -

Identifier Source: org_study_id

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