NCT01950988

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 27, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 26, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2016

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

2.9 years

First QC Date

August 27, 2013

Last Update Submit

February 26, 2024

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Measurement of the dental plaque index

    up to 3 months

Secondary Outcomes (1)

  • Patient satisfaction

    up to 3 months

Study Arms (3)

Children

OTHER
Device: Manual toothbrush referenceProcedure: Measure of the dental plaqueDevice: Manual toothbrush Broscyl®

Adults

OTHER
Device: Manual toothbrush referenceProcedure: Measure of the dental plaqueDevice: Manual toothbrush Broscyl®

Elderly people

OTHER
Device: Manual toothbrush referenceProcedure: Measure of the dental plaqueDevice: Manual toothbrush Broscyl®

Interventions

Manual toothbrush referenceDEVICE
AdultsChildrenElderly people
Measure of the dental plaquePROCEDURE
AdultsChildrenElderly people
Manual toothbrush Broscyl®DEVICE
AdultsChildrenElderly people

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon

Dijon, 21000, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2013

First Posted

September 26, 2013

Study Start

July 16, 2013

Primary Completion

June 8, 2016

Study Completion

June 8, 2016

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations

FR(1)