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

Primary Purpose

Cerebral Palsy;, Dental Plaque

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
manual brushing
electric toothbrush linked
off electric toothbrush
Sponsored by
Federal University of the Valleys of Jequitinhonha and Mucuri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebral Palsy; focused on measuring Cerebral Palsy;, Toothbrushing;, Dental Plaque

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • medical diagnosis of cerebral palsy

Exclusion Criteria:

  • who did not complete the cycle three brushings

Sites / Locations

  • Universidade Federal dos Vales do Jequitinhonha e Mucuri

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

manual brushing

electric toothbrush linked

off electric toothbrush

Arm Description

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

Outcomes

Primary Outcome Measures

Removal of dental plaque
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.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2014
Last Updated
April 11, 2014
Sponsor
Federal University of the Valleys of Jequitinhonha and Mucuri
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1. Study Identification

Unique Protocol Identification Number
NCT02114801
Brief Title
Mechanical Control of Plaque in Patients With Cerebral Palsy: A Randomized Clinical Trial
Official Title
Mechanical Control of Plaque in Patients With Cerebral Palsy: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal University of the Valleys of Jequitinhonha and Mucuri

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy;, Dental Plaque
Keywords
Cerebral Palsy;, Toothbrushing;, Dental Plaque

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
manual brushing
Arm Type
Experimental
Arm Description
manual brushing; Oral-B®, Stages 4, Rio de Janeiro, Rio de Janeiro;
Arm Title
electric toothbrush linked
Arm Type
Experimental
Arm Description
electric toothbrush linked; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro
Arm Title
off electric toothbrush
Arm Type
Experimental
Arm Description
off electric toothbrush; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro
Intervention Type
Device
Intervention Name(s)
manual brushing
Other Intervention Name(s)
manual brushing; (Oral-B®, Stages 4, Rio de Janeiro, Rio de Janeiro)
Intervention Description
Tooth brushing
Intervention Type
Device
Intervention Name(s)
electric toothbrush linked
Other Intervention Name(s)
electric toothbrush linked; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro
Intervention Description
Tooth brushing
Intervention Type
Device
Intervention Name(s)
off electric toothbrush
Other Intervention Name(s)
off electric toothbrush; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro
Intervention Description
Tooth brushing
Primary Outcome Measure Information:
Title
Removal of dental plaque
Description
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.
Time Frame
after brushing three minutes duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: medical diagnosis of cerebral palsy Exclusion Criteria: who did not complete the cycle three brushings
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nayara Kelly Lyrio Ferraz, MsC
Organizational Affiliation
Federal University of the Valleys of Jequitinhonha and Mucuri
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal dos Vales do Jequitinhonha e Mucuri
City
Diamantina
State/Province
Minas Gerais
ZIP/Postal Code
39100000
Country
Brazil

12. IPD Sharing Statement

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

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