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

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ClinicalTrials.gov Identifier: NCT02114801
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : April 15, 2014
Sponsor:
Information provided by (Responsible Party):
Federal University of the Valleys of Jequitinhonha and Mucuri

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy; Dental Plaque Device: manual brushing Device: electric toothbrush linked Device: off electric toothbrush Not Applicable

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  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mechanical Control of Plaque in Patients With Cerebral Palsy: A Randomized Clinical Trial
Study Start Date : March 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: manual brushing
manual brushing; Oral-B®, Stages 4, Rio de Janeiro, Rio de Janeiro;
Device: manual brushing
Tooth brushing
Other Name: 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 Name: 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 Name: off electric toothbrush; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • medical diagnosis of cerebral palsy

Exclusion Criteria:

  • who did not complete the cycle three brushings

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114801


Locations
Brazil
Universidade Federal dos Vales do Jequitinhonha e Mucuri
Diamantina, Minas Gerais, Brazil, 39100000
Sponsors and Collaborators
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

Responsible Party: Federal University of the Valleys of Jequitinhonha and Mucuri
ClinicalTrials.gov Identifier: NCT02114801     History of Changes
Other Study ID Numbers: 358.350/2013
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014

Keywords provided by Federal University of the Valleys of Jequitinhonha and Mucuri:
Cerebral Palsy;
Toothbrushing;
Dental Plaque

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Dental Plaque
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Dental Deposits
Tooth Diseases
Stomatognathic Diseases