Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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REBEC |
Last refreshed on:
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29 May 2023 |
Main ID: |
RBR-2v3k6r |
Date of registration:
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29/01/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Speech changes produced by upper orthodontic retainers
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Scientific title:
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Speech changes produced by upper orthodontic retainers: Prospective Randomized Clinical Trial |
Date of first enrolment:
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20/07/2015 |
Target sample size:
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Recruitment status: |
Recruitment completed |
URL:
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http://ensaiosclinicos.gov.br/rg/RBR-2v3k6r |
Study type:
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Intervention |
Study design:
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A treatment clinical trial, crossover, with four arms, single-blinded, randomized and prospective
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Diego Coelho
Lorenzoni |
Address:
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Departamento de Ortodontia - Faculdade de Odontologia de Bauru - USP, Alameda Octávio Pinheiro Brisolla, 9-75
17012-901
Bauru
Brazil |
Telephone:
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+55-11-3235-8217 |
Email:
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dclorenzoni@yahoo.com.br |
Affiliation:
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Diego Coelho Lorenzoni |
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Name:
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Diego Coelho
Lorenzoni |
Address:
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Departamento de Ortodontia - Faculdade de Odontologia de Bauru - USP, Alameda Octávio Pinheiro Brisolla, 9-75
17012-901
Bauru
Brazil |
Telephone:
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+55-11-3235-8217 |
Email:
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dclorenzoni@yahoo.com.br |
Affiliation:
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Diego Coelho Lorenzoni |
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Key inclusion & exclusion criteria
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Inclusion criteria: Brazilians who speak the native Portuguese; acceptable sagittal occlusal relationship, with molars class I or variations of up to ¼ of II or III class.
Exclusion criteria: Presence of cross bite, open bite, overbite greater than 50%, overjet greater than 4 mm, crowding greater than 2 mm and multiple anterior diastema; orthodontic treatment recently finalized (less than 1 year); recently used upper orthodontic retainer (less than 2 months); presence of ankyloglossia; presence of TMD; presence of previous change in speech.
Age minimum:
19Y
Age maximum:
41Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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Speech changes; orthodontic retainer, malocclusion
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C07.793.494
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C23.550.291.937
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E06.658.578
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Intervention(s)
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E05.320.274
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Device
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This study will have a crossover design. Control group: Group I - 20 adult volunteers will use the upper conventional wrap-around orthodontic retainer during 21 days; Experimental Groups: Group II - the same 20 adult volunteers will use the upper horseshoe-shaped wrap-around orthodontic retainer during 21 days; Group III - the same 20 adult volunteers will use the upper wrap-around with an anterior hole orthodontic retainer during 21 days; Group IV - the same 20 adult volunteers will use the upper thermoplastic clear retainer during 21 days. After use each appliance for 21 days, volunteer will remain seven days without using any device, until start the next retainer. Changes caused by each appliance and comparisons of these changes between the different retainers will be made with the acoustic analysis of speech formants in Praat 5404 computerized program, and the auditory perceptual analysis of speech carried out by two speech therapists, in speech excerpts recorded in three times: immediately before and after each retainers installation and after 21 days of use thereof. To investigate the perception of volunteers about the appliances, a visual analog scale of 100 mm will be applied to each feature assessed after each retainer be used.
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Primary Outcome(s)
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Changes in speech caused by different upper removable orthodontic retainers at the time of installation and after 21 days of device use, checked by acoustic analysis of formants and auditory perceptual analysis of speech, and will be considered a variation of 5% the measurements pre, post and immediately after 21 days of installation of the devices.
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Secondary Outcome(s)
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Differences in perception of patients to several factors during 21 days of upper orthodontic retainers use, assessed by a visual analog scale of 100 mm, and will be considered a difference of 5% between devices.
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Source(s) of Monetary Support
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES
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Faculdade de Odontologia de Bauru - USP
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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