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
About this trial
This is an interventional prevention trial for Cerebral Palsy; focused on measuring Cerebral Palsy;, Toothbrushing;, Dental Plaque
Eligibility Criteria
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
NCT ID
NCT02114801
First Posted
March 20, 2014
Last Updated
April 11, 2014
Sponsor
Federal University of the Valleys of Jequitinhonha and Mucuri
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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