NCT00836784

Brief Summary

This study aimed to validate or invalidate non-inferiority in the plaque removal efficacy of old versus new toothbrushes in the hands of 7-9 year old children. This study was conducted in 93 Iranian students aged between 7-9 year old.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

May 5, 2009

Status Verified

May 1, 2009

Enrollment Period

28 days

First QC Date

February 3, 2009

Last Update Submit

May 4, 2009

Conditions

Plaque Removal

Keywords

Old tooth brushPlaque removal

Outcome Measures

Primary Outcomes (1)

  • Turesky plaque index

    before and after brushing the teeth

Study Arms (2)

1

EXPERIMENTAL
Other: old toothbrush

2

EXPERIMENTAL
Other: New tooth brush

Interventions

old toothbrushOTHER

All children will receive new tooth brush 3 months before starting the study, at the end of 3 month the worn tooth brushes will be returned and the surface area within the outline will be determine using NIH (national institutes of health) image software.

Also known as: worn toothbrush
1
New tooth brushOTHER

The tooth brush which will be use in this study is "Jordan". A new Jordan toothbrush will be give to all children, and in "new tooth brush" group they will use these toothbrushes.

Also known as: unused toothbrush
2

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • subjects should be have central and lateral incisors, first permanent molar in each quadrant of maxilla and mandible
  • they should be without restoration on facial, lingual surfaces
  • subjects should be healthy without any disabilities

You may not qualify if:

  • subjects who wearing oral prosthesis,orthodontic brackets or removable appliances
  • subjects using mouthwashes which improve the oral hygiene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Beheshti University

Tehran, Iran

Location

Study Officials

  • Beheshte Malekafzali

    Shahid Beheshti medical Science University

    STUDY CHAIR

  • Mina Biria

    Shahid Beheshti medical Science University

    STUDY DIRECTOR

  • Hoshyar Abbasi

    Shahid Beheshti Medical Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 4, 2009

Study Start

February 1, 2009

Primary Completion

March 1, 2009

Study Completion

April 1, 2009

Last Updated

May 5, 2009

Record last verified: 2009-05

Locations

IR(1)