Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000767000
Ethics application status
Approved
Date submitted
27/08/2010
Date registered
15/09/2010
Date last updated
15/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Myofunctional therapy in predominant mouth breathers
Scientific title
Myofunctional therapy in predominant mouth breathers to evaluate the electromyographic signal of the orbicularis oris muscles and the clinical and anthropometric changes of these subjects.
Secondary ID [1] 252585 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mouth breathing of children 258079 0
Condition category
Condition code
Respiratory 258251 258251 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The children with mouth breathing were submitted to the speech-language, orthodontic and otorhinolaryngological evaluations to confirm their adequacy in the inclusion and exclusion criteria. To reach the objectives of this study, they were submitted to clinical, anthropometric (the height of the upper lip, corresponding to the distance between the subnasale and the stomion points and the height of the filter, corresponding to the distance between the subnasale and the upper lip points) and electromyographic (upper and lower orbicularis oris muscles at rest, during isometry -maximum voluntary contraction, sucking, swallowing and speech) evaluation.
The study collected data in three different measurements sessions. 1. at the initial evaluation for both groups 2. only for the study group, at the partial evaluation after 10 days of daily exercises and at the final evaluation, after 40 days of intervention 3 times per week. The maximum time of 40 days was chosen based on Saxon and Schneider (1995), who stated that some important physiological changes are observed in the first 6 to 8 weeks of muscular training.
After the initial evaluation, the parents or tutors and the children of the study group were oriented about the use the labial exerciser with a trained speech-language therapist.
First, it was recommended two exercises, one isotonic (open and close the mouth slowly, including lips and jaw, in order to achieve a complete closing of the Labial Exerciser) and one isometric (similar to the anterior movement but keeping the labial exerciser closed for about 30 seconds). They should be done in a frequency of 4 times to the day, with 15 repetitions each exercise.
The 15 times was chosen based on the frequency of 10 to 20 times proposed by the Jardini (1999) that it carried through study with similar methodology of this . The break between the exercises should be the same time of exercise period, that is, 30 seconds.
The electromyographic reevaluation with 10 and 40 days, followed the same conditions of the initial evaluation.
Intervention code [1] 257107 0
Diagnosis / Prognosis
Intervention code [2] 257180 0
Treatment: Other
Intervention code [3] 257181 0
Rehabilitation
Comparator / control treatment
The control group were submitted to clinical, anthropometric and electromyographic evaluation, but had not received any treatment. The children had been equalized in sex and age in both the groups
Control group
Active

Outcomes
Primary outcome [1] 259096 0
After the treatment significant reduction in the electrical activity on the muscles during the swallowing and speech was verified, while significant increase was observed in the isometry and sucking. In the test of rest, even so with no statistical significance, also there was increase of the muscular activity.
For electromyographic collection, active pre-amplifiers was used with differential plug, by Lynx Electronical Technology, connected to the double electrodes. The electrodes had a round shape, fix distance of 20 mm between the same, 10 mm of diameter and 2 mm of contact surface, conductor gel in a fix quantity applied by the manufacturer, gain of 20X, and rejection rate of common mode > 100 dB.
The electromyographic signals were conditioned and amplified using the equipment EMG 1200 (Lynx Tecnologia ltda.), with 8 channels of entrance, transformer A/D of 16 bits and band of entrance +/-2V. It was used 2KHz of frequency of sampling, filter type Butterworth, high-pass and low-pass frequency filter of 10Hz and 1000Hz, respectively. The signals were collected by the Software BioInspector 1.8. (Lynx), quantified in RMS (root mean square), expressed in microvolt and stored in a portable computer, without connection to the electrical net to avoid the interference in the electromyographic signal.
Timepoint [1] 259096 0
At the end of 10 days of daily exercises with the therapist, and after 40 more days of the 3 times per week.
Secondary outcome [1] 265391 0
After the treatment, was verified, through the data of the clinical evaluation, that the use of the labial exerciser propitiated positive effects, mainly regarding the position of the lips, and to the functions of sucking, swallowing, mastication and respiration.
The average of the anthropometric measures of the study group and the control group, showed there were that changes in the height of the filter and the upper lip, with statistically significant difference.
Timepoint [1] 265391 0
At the end of 10 days of daily exercises with the therapist, and after 40 more days of the 3 times per week.

Eligibility
Key inclusion criteria
All subjects were submitted to nasal permeability examination in order to evaluate obstruction and classify the mouth breathing in organic or functional. Functional mouth breathers were included in Study Group. Children with normal nasal permeability and without features of mouth breather were included in Control Group.
Minimum age
6 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects which have been submitted in a myofunctional therapy before or who showed evidences of neurological implications were excluded from the work. Subjects with significant occlusal modification that prevents the spontaneous lip sealing.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment outside Australia
Country [1] 2841 0
Brazil
State/province [1] 2841 0

Funding & Sponsors
Funding source category [1] 257584 0
Self funded/Unfunded
Name [1] 257584 0
Angela Ruviaro Busanello
Country [1] 257584 0
Brazil
Primary sponsor type
Individual
Name
Angela Ruviaro Busanello
Address
Street: General Neto, number 484
State: Rio Grande do Sul
CEP: 97050-240
Country
Brazil
Secondary sponsor category [1] 256775 0
Individual
Name [1] 256775 0
Ana Maria Toniolo da Silva
Address [1] 256775 0
Street: Angelo Bolson, number 338
State: Rio Grande do Sul
CEP: 97050-100
Country [1] 256775 0
Brazil
Secondary sponsor category [2] 256811 0
Individual
Name [2] 256811 0
Ana Maria Toniolo da Silva
Address [2] 256811 0
Street: Angelo Bolson, number 338
State: Rio Grande do Sul
CEP: 97050-100
Country [2] 256811 0
Brazil

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31582 0
Address 31582 0
Country 31582 0
Phone 31582 0
Fax 31582 0
Email 31582 0
Contact person for public queries
Name 14829 0
Angela Ruviaro Busanello
Address 14829 0
Street: General Neto, number 484
State: Rio Grande do Sul
CEP: 97050-240
Country 14829 0
Brazil
Phone 14829 0
(55)81282850
Fax 14829 0
Email 14829 0
angelafonoaudiologia@yahoo.com.br
Contact person for scientific queries
Name 5757 0
Angela Ruviaro Busanello
Address 5757 0
Street: General Neto, number 484
State: Rio Grande do Sul
CEP: 97050-240
Country 5757 0
Brazil
Phone 5757 0
(55)81282850
Fax 5757 0
Email 5757 0
angelafonoaudiologia@yahoo.com.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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