Rehabilitative Management of Mastication
1 other identifier
interventional
17
1 country
1
Brief Summary
The purpose of this study is to verify the effectiveness of a systematic rehabilitative program for mastication in patients submitted to orthognathic surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 surgery
Started Mar 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 21, 2012
CompletedFirst Posted
Study publicly available on registry
March 23, 2012
CompletedMarch 23, 2012
March 1, 2012
11 months
March 21, 2012
March 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evidence of clinical improvement in mastication after oral-motor rehabilitative program
improvement is verified through a clinical orofacial myofunctional evaluation using a standardized protocol with scores (orofacial mobility, masticatory/deglutition clinical performance, jaw movements) and by variations in the activation of the masseter and temporal muscles (surface electromyography)
within the first year after surgery (plus or minus 2 weeks)
Study Arms (3)
Experimental group
EXPERIMENTALInclusion criteria were: Skeletal Class III orthognathic surgery patients; adults (age above 18 years), agreement to perform orthognathic surgery and to undergo all of the necessary procedures determined by the multidisciplinary team (i.e. orthodontic preparation, clinical orofacial myofunctional and electromyographic assessment, surgery, post surgery orthodontic treatment, post surgery clinical orofacial myofunctional and electromyographic assessment and orofacial myofunctional treatment when necessary). Exclusion criteria were: previous orthognathic surgery; previous head and neck surgery; neurologic and/or systemic diseases; facial trauma; syndromes; cognitive impairment; and communication and hearing deficits.
Instruction Group
ACTIVE COMPARATORInclusion criteria were: Skeletal Class III orthognathic surgery patients, adults (age above 18 years), agreement to perform orthognathic surgery and to undergo all of the necessary procedures determined by the multidisciplinary team (i.e. orthodontic preparation, clinical orofacial myofunctional and electromyographic assessment, surgery, post surgery orthodontic treatment, post surgery clinical orofacial myofunctional and electromyographic assessment and orofacial myofunctional treatment when necessary). Exclusion criteria were: previous orthognathic surgery; previous head and neck surgery; neurologic and/or systemic diseases; facial trauma; syndromes; cognitive impairment; and communication and hearing deficits.
Control group
NO INTERVENTIONInclusion criteria for this group were: adults (age above 18 years); absence of stomatognathic system alterations; absence of alterations in the scapular region; complete permanent dentition (absence/extraction of the third molar was accepted); Skeletal and Angle's Class I facial pattern; and absence of malocclusion. Exclusion criteria were: previous orthodontic treatment; and history of previous oral motor intervention.
Interventions
Once a week for six weeks, the experimental group received a forty minutes session of orofacial myofunctional treatment. A home exercise program was prescribed during each session. The protocol implies in continuous and daily practices - participants were asked to perform exercises at least three times a day. After the first six weeks, the experimental group underwent four sessions for maintenance purposes (two sessions twice a month and two sessions once a month). The total treatment duration was of five months.
The instruction group underwent two supervised forty minutes therapy sessions along the six weeks following surgery. These sessions involved the perception of the stomatognathic system, especially in terms of adequate performance during mastication. Specific exercises were not given and patients were instructed to try to reproduce the adequate pattern of mastication at all meals (i.e. alternated bilateral, with lip closure; with coordination activity of the tongue and mandible).
As the sEMG test-retest is a critical issue, participants of CG were also tested in two distinct moments (testing occurred with 1 year interval) in order to verify possible changes in the sEMG measurements as a result of retesting.
Eligibility Criteria
You may qualify if:
- Skeletal Class III orthognathic surgery patients
- adults (age above 18 years)
- agreement to perform orthognathic surgery
- agreement to undergo all of the necessary procedures determined by the multidisciplinary team
You may not qualify if:
- previous orthognathic surgery
- previous head and neck surgery
- neurologic and/or systemic diseases
- facial trauma
- syndromes
- cognitive impairment
- communication and hearing deficits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital das Clinicas, University of São Paulo
São Paulo, São Paulo, 05403-000, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Claudia RF Andrade, Professor
School of Medicine, University of São Paulo
- PRINCIPAL INVESTIGATOR
Laura D Mangilli, Ph.D.
School of Medicine, University of São Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2012
First Posted
March 23, 2012
Study Start
March 1, 2009
Primary Completion
February 1, 2010
Study Completion
October 1, 2011
Last Updated
March 23, 2012
Record last verified: 2012-03