Effectiveness of a Novel Concept for a Manual Toothbrush... | NCT01950988

Studies
Effectiveness of a Novel Concept for a Manual Toothbrush Broscyl®

NCT01950988

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Terminated

Last Update Posted

Feb 28, 2024Actual

Enrollment

142Actual

Phase

Not Applicable

Conditions

Healthy Subjects

Interventions

Manual toothbrush reference
Measure of the dental plaque
Manual toothbrush Broscyl®

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of inclusion

Expanded Access Info

Start Date

Jul 16, 2013Actual

Primary Completion Date

Jun 8, 2016Actual

Completion Date

Jun 8, 2016Actual

First Submitted Date

Aug 27, 2013

First Submission Date that Met QC Criteria

Sep 25, 2013

First Posted Date

Sep 26, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2024

Last Update Posted Date

Feb 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

142Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Children	Other	Device: Manual toothbrush reference Procedure: Measure of the dental plaque Device: Manual toothbrush Broscyl®
Adults	Other	Device: Manual toothbrush reference Procedure: Measure of the dental plaque Device: Manual toothbrush Broscyl®
Elderly people	Other	Device: Manual toothbrush reference Procedure: Measure of the dental plaque Device: Manual toothbrush Broscyl®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Manual toothbrush reference	Device		Adults Children Elderly people
Measure of the dental plaque

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of the dental plaque index		up to 3 months

Secondary Outcomes

Measure	Description	Time Frame
Patient satisfaction	self-completed questionnaire	up to 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided