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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: REBEC
Last refreshed on: 29 May 2023
Main ID:  RBR-2v3k6r
Date of registration: 29/01/2016
Prospective Registration: No
Primary sponsor: Faculdade de Odontologia de Bauru - USP
Public title: Speech changes produced by upper orthodontic retainers
Scientific title: Speech changes produced by upper orthodontic retainers: Prospective Randomized Clinical Trial
Date of first enrolment: 20/07/2015
Target sample size:
Recruitment status: Recruitment completed
URL:  http://ensaiosclinicos.gov.br/rg/RBR-2v3k6r
Study type:  Intervention
Study design:  A treatment clinical trial, crossover, with four arms, single-blinded, randomized and prospective  
Phase:  N/A
Countries of recruitment
Brazil
Contacts
Name: Diego Coelho   Lorenzoni
Address:  Departamento de Ortodontia - Faculdade de Odontologia de Bauru - USP, Alameda Octávio Pinheiro Brisolla, 9-75 17012-901 Bauru Brazil
Telephone: +55-11-3235-8217
Email: dclorenzoni@yahoo.com.br
Affiliation:  Diego Coelho Lorenzoni
Name: Diego Coelho   Lorenzoni
Address:  Departamento de Ortodontia - Faculdade de Odontologia de Bauru - USP, Alameda Octávio Pinheiro Brisolla, 9-75 17012-901 Bauru Brazil
Telephone: +55-11-3235-8217
Email: dclorenzoni@yahoo.com.br
Affiliation:  Diego Coelho Lorenzoni
Key inclusion & exclusion criteria
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: -
Health Condition(s) or Problem(s) studied
Speech changes; orthodontic retainer, malocclusion
C07.793.494
C23.550.291.937
E06.658.578
Intervention(s)
E05.320.274
Device
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.
Primary Outcome(s)
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.
Secondary Outcome(s)
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.
Secondary ID(s)
Source(s) of Monetary Support
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES
Faculdade de Odontologia de Bauru - USP
Secondary Sponsor(s)
Diego Coelho Lorenzoni
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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