Randomized Trial to Evaluate the Efficacy of Two Different Toothbrushes on Plaque Control
NCT ID: NCT03099551
Last Updated: 2017-04-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE4
Total Enrollment
56 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-12-31
Study Completion Date
2017-06-30
Brief Summary
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The aim of the present study was to evaluate the efficacy of two different toothbrushes (manual and sonic) on plaque control
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Detailed Description
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A parallel randomized clinical trial, examiner-blind, was conducted involving 56 patients with ages from 15 to 20, all students of CAMP (Centro de Formação e Integração Social), in the city of São Bernardo do Campo, state of São Paulo, Brazil. Randomization: the subjects were randomly allocated to two different groups (A for the manual toothbrush and B for the sonic toothbrush) by removing from an urn a paper with their respective group. Silness \& Löe Gingival Index, the Turesky Modification of the Quigley Hein Plaque Index and the Community Periodontal Index were evaluated at baseline and after 3 and 6 months.
Conditions
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Plaque
Gingivitis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
OTHER
Blinding Strategy
SINGLE
Investigators
Study Groups
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Manual Toothbrush users
Group using manual toothbrush Curaprox 5460 Ultra Soft
Group Type
ACTIVE_COMPARATOR
Group using manual toothbrush Curaprox 5460 Ultra Soft
Intervention Type
DEVICE
Manual toothbrush usage with Bass technique twice a day during 2 minutes
Sonic Toothbrush users
Group using sonic toothbrush Edel White
Group Type
ACTIVE_COMPARATOR
Group using sonic toothbrush Edel White
Intervention Type
DEVICE
Sonic toothbrush usage twice a day during 2 minutes
Interventions
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Group using manual toothbrush Curaprox 5460 Ultra Soft
Manual toothbrush usage with Bass technique twice a day during 2 minutes
Intervention Type
DEVICE
Group using sonic toothbrush Edel White
Sonic toothbrush usage twice a day during 2 minutes
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Subjects had to be in generally good health, and possessing a minimum of 20 permanent natural teeth, excluding third molars.
Exclusion Criteria
* Subjects were excluded if they had fixed orthodontic appliances, advanced periodontal disease, limited manual dexterity, active caries, medical conditions limiting their salivary function or immunological condition, and if they were smokers.
Minimum Eligible Age
15 Years
Maximum Eligible Age
20 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Faculty Sao Leopoldo Mandic Campinas
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
References
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Related Links
Access external resources that provide additional context or updates about the study.
http://dab.saude.gov.br/CNSB/sbbrasil/arquivos/projeto_sb2010_relatorio_final.pdf
Brazil. Ministry of Health. Healthcare Department/Health Inspection Office. Department of Basic Healthcare. General Management of Oral Health. SBBrasil: principal results. Brasília: Ministry of Health; 2010.
Other Identifiers
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1.672.795
Identifier Type: -
Identifier Source: org_study_id
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