Mechanical Control of Plaque in Patients With Cerebral Palsy: A Randomized Clinical Trial
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 20, 2014
CompletedFirst Posted
Study publicly available on registry
April 15, 2014
CompletedApril 15, 2014
April 1, 2014
1.4 years
March 20, 2014
April 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
after brushing three minutes duration
Study Arms (3)
manual brushing
EXPERIMENTALmanual brushing; Oral-B®, Stages 4, Rio de Janeiro, Rio de Janeiro;
electric toothbrush linked
EXPERIMENTALelectric toothbrush linked; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro
off electric toothbrush
EXPERIMENTALoff electric toothbrush; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro
Interventions
Tooth brushing
Tooth brushing
Tooth brushing
Eligibility Criteria
You may qualify if:
- medical diagnosis of cerebral palsy
You may not qualify if:
- who did not complete the cycle three brushings
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal dos Vales do Jequitinhonha e Mucuri
Diamantina, Minas Gerais, 39100000, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nayara Kelly Lyrio Ferraz, MsC
Federal University of the Valleys of Jequitinhonha and Mucuri
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2014
First Posted
April 15, 2014
Study Start
March 1, 2012
Primary Completion
August 1, 2013
Study Completion
December 1, 2013
Last Updated
April 15, 2014
Record last verified: 2014-04