Mechanical Control of Plaque in Patients With Cerebral Palsy: A Randomized Clinical Trial

April 11, 2014 updated by: Federal University of the Valleys of Jequitinhonha and Mucuri
The aim of the present study was to determine the effectiveness of brushing with an electric toothbrush switched on and switched off in comparison to manual brushing for the removal of dental plaque in children aged four to 16 years with cerebral palsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Advances in the design and type of movement of electric toothbrushes can determine the increase in effectiveness in the control of biofilm by caregivers and patients.There is a paucity of studies evaluating the effectiveness of the electric toothbrush compared to manual toothbrush specifically in patients with cerebral palsy.Only one study used the electric toothbrush in patients with cerebral palsy and demonstrated superiority of the electric toothbrush over the manual. However, the study investigated the effect of various cleaning strategies on symptoms of gingival inflammation, not specifically focusing on the comparison of the efficiency of removal of biofilm from the manual toothbrush and electric toothbrush. The primary objective of this study was to evaluate the effectiveness of the electric brush on and off the removal of dental plaque in subjects with cerebral palsy compared to manual toothbrush. The secondary objective was to characterize the study as socioeconomic population.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Diamantina, Minas Gerais, Brazil, 39100000
        • Universidade Federal dos Vales do Jequitinhonha e Mucuri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • medical diagnosis of cerebral palsy

Exclusion Criteria:

  • who did not complete the cycle three brushings

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: manual brushing
manual brushing; Oral-B®, Stages 4, Rio de Janeiro, Rio de Janeiro;
Device: manual brushing
Tooth brushing
Other Names:
  • manual brushing; (Oral-B®, Stages 4, Rio de Janeiro, Rio de Janeiro)
Experimental: electric toothbrush linked
electric toothbrush linked; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro
Device: electric toothbrush linked
Tooth brushing
Other Names:
  • electric toothbrush linked; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro
Experimental: off electric toothbrush
off electric toothbrush; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro
Device: off electric toothbrush
Tooth brushing
Other Names:
  • off electric toothbrush; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Removal of dental plaque
Time Frame: after brushing three minutes duration

Before and after brushings were assessed levels of plaque accumulation. For evaluation of the dental plaque index of Quigley-Hein plaque modified Turesky was used.

The escovções were performed by caregivers.
after brushing three minutes duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of the Valleys of Jequitinhonha and Mucuri

Investigators

  • Principal Investigator: Nayara Kelly Lyrio Ferraz, MsC, Federal University of the Valleys of Jequitinhonha and Mucuri

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 20, 2014

First Submitted That Met QC Criteria

April 11, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Estimate)

April 15, 2014

Last Update Submitted That Met QC Criteria

April 11, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 358.350/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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