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

NCT ID: NCT02114801

Last Updated: 2014-04-15

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebral Palsy; Dental Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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manual brushing

manual brushing; Oral-B®, Stages 4, Rio de Janeiro, Rio de Janeiro;

Group Type EXPERIMENTAL

manual brushing

Intervention Type DEVICE

Tooth brushing

electric toothbrush linked

electric toothbrush linked; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro

Group Type EXPERIMENTAL

electric toothbrush linked

Intervention Type DEVICE

Tooth brushing

off electric toothbrush

off electric toothbrush; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro

Group Type EXPERIMENTAL

off electric toothbrush

Intervention Type DEVICE

Tooth brushing

Interventions

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manual brushing

Tooth brushing

Intervention Type DEVICE

electric toothbrush linked

Tooth brushing

Intervention Type DEVICE

off electric toothbrush

Tooth brushing

Intervention Type DEVICE

Other Intervention Names

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manual brushing; (Oral-B®, Stages 4, Rio de Janeiro, Rio de Janeiro) electric toothbrush linked; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro off electric toothbrush; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro

Eligibility Criteria

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Inclusion Criteria

* medical diagnosis of cerebral palsy

Exclusion Criteria

* who did not complete the cycle three brushings
Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of the Valleys of Jequitinhonha and Mucuri

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nayara Kelly Lyrio Ferraz, MsC

Role: PRINCIPAL_INVESTIGATOR

Federal University of the Valleys of Jequitinhonha and Mucuri

Locations

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Universidade Federal dos Vales do Jequitinhonha e Mucuri

Diamantina, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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358.350/2013

Identifier Type: -

Identifier Source: org_study_id

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