Cerebral Palsy;NCT02114801
Mechanical Control of Plaque in Patients With Cerebral Palsy: A Randomized Clinical Trial
A study testing manual brushing, electric toothbrush linked and off electric toothbrush in people with Cerebral Palsy; and Dental Plaque, run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Cerebral Palsy;, Dental Plaque
- What is being tested?
- manual brushing, electric toothbrush linked and off electric toothbrush
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- medical diagnosis of cerebral palsy
Who cannot join
- who did not complete the cycle three brushings
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal dos Vales do Jequitinhonha e Mucuri
Diamantina, Minas Gerais, 39100000
About this study
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.
Read the 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.
- Conditions
- Cerebral Palsy;, Dental Plaque
- Being tested
- manual brushing, electric toothbrush linked, off electric toothbrush
- Keywords
- Cerebral Palsy;, Toothbrushing;, Dental Plaque
- Medical subject headings
- Cerebral Palsy, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual brushingDevice
Also called manual brushing; (Oral-B®, Stages 4, Rio de Janeiro, Rio de Janeiro)
Tooth brushing
electric toothbrush linkedDevice
Also called electric toothbrush linked; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro
Tooth brushing
off electric toothbrushDevice
Also called off electric toothbrush; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro
Tooth brushing
| Study group | Role | What they receive |
|---|---|---|
| manual brushing | Experimental | manual brushing; Oral-B®, Stages 4, Rio de Janeiro, Rio de Janeiro; Receives: Device: manual brushing |
| electric toothbrush linked | Experimental | electric toothbrush linked; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro Receives: Device: electric toothbrush linked |
| off electric toothbrush | Experimental | off electric toothbrush; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro Receives: Device: off electric toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after brushing three minutes duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startMar 2012
- Primary completionAug 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy;Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and Mucuri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nayara Kelly Lyrio Ferraz, MsC, Principal investigator, Federal University of the Valleys of Jequitinhonha and Mucuri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114801
- Sponsor's protocol ID
- 358.350/2013
- Status last verified
- Apr 2014
- First submitted
- 20 Mar 2014
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Control of Plaque in Patients With Cerebral Palsy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02114801
- Acronym / sponsor ID
- 358.350/2013
- Conditions
- Cerebral Palsy;, Dental Plaque
- Keywords
- Cerebral Palsy;, Toothbrushing;, Dental Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and MucuriUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| manual brushing | Experimental | Device: manual brushingmanual brushing; Oral-B®, Stages 4, Rio de Janeiro, Rio de Janeiro; |
| electric toothbrush linked | Experimental | Device: electric toothbrush linkedelectric toothbrush linked; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro |
| off electric toothbrush | Experimental | Device: off electric toothbrushoff electric toothbrush; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- medical diagnosis of cerebral palsy
Key exclusion criteria (1 listed)
- who did not complete the cycle three brushings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| manual brushingAlso: manual brushing; (Oral-B®, Stages 4, Rio de Janeiro, Rio de Janeiro)Tooth brushing | Device | manual brushing |
| electric toothbrush linkedAlso: electric toothbrush linked; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de JaneiroTooth brushing | Device | electric toothbrush linked |
| off electric toothbrushAlso: off electric toothbrush; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de JaneiroTooth brushing | Device | off electric toothbrush |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayara Kelly Lyrio Ferraz, MsC principal investigator
Federal University of the Valleys of Jequitinhonha and Mucuri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual brushing, electric toothbrush linked and off electric toothbrush in people with Cerebral Palsy; and Dental Plaque, run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Removal of dental plaque (time frame: after brushing three minutes duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2014.