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Completed

NCT Number: NCT02114801

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

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.

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Key information

Conditions

Cerebral Palsy; Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Dental Deposits Dental Plaque Nervous System Diseases Stomatognathic Diseases Tooth Diseases

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal dos Vales do Jequitinhonha e Mucuri

Diamantina, Minas Gerais, 39100000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • medical diagnosis of cerebral palsy

Exclusion criteria

  • who did not complete the cycle three brushings

Treatment and study plan

manual brushing

Device

Tooth brushing

Other names: manual brushing; (Oral-B®, Stages 4, Rio de Janeiro, Rio de Janeiro)

electric toothbrush linked

Device

Tooth brushing

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

off electric toothbrush

Device

Tooth brushing

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Federal University of the Valleys of Jequitinhonha and Mucuri

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 15, 2014
Registry last updated
Apr 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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