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Rehabilitative Management of Mastication

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01562249
First received: March 21, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose

The purpose of this study is to verify the effectiveness of a systematic rehabilitative program for mastication in patients submitted to orthognathic surgery.


Condition Intervention Phase
Surgery
Malocclusion
Other: orofacial myofunctional treatment protocol
Other: counseling
Other: Control Group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Rehabilitative Management of Mastication After Orthognathic Surgery: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Evidence of clinical improvement in mastication after oral-motor rehabilitative program [ Time Frame: within the first year after surgery (plus or minus 2 weeks) ] [ Designated as safety issue: No ]
    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)


Enrollment: 17
Study Start Date: March 2009
Study Completion Date: October 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental group
Inclusion 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.
Other: orofacial myofunctional treatment protocol
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.
Other Name: rehabilitative orofacial myofunctional protocol
Active Comparator: Instruction Group
Inclusion 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.
Other: counseling
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).
Other Name: supervised instruction
No Intervention: Control group
Inclusion 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.
Other: Control Group
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.
Other Names:
  • healthy individuals
  • no intervention

Detailed Description:

Orthognathic surgery can produce complications during the postoperative period - i.e. situations of acute pain and inflammation - as a consequence of fractures and incisions in the mucosa. The inadequate management of soft tissue and prolonged surgical time could be the causes of acute facial oedema, hematoma and ecchymosis in the face and neck, as well as functional disorders involving swallowing and breathing, which can affect patients' integrity.

Despite the fact that decreased muscular extensibility and strength, increased muscular fatigability, hipomobility, and alteration of the biomechanical efficiency and length of the masticatory muscles are documented clinical consequences, no systematic method of obviating such problems through muscular rehabilitation has yet been published

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • previous orthognathic surgery
  • previous head and neck surgery
  • neurologic and/or systemic diseases
  • facial trauma
  • syndromes
  • cognitive impairment
  • communication and hearing deficits
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562249

Locations
Brazil
Hospital das Clinicas, University of São Paulo
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01562249     History of Changes
Other Study ID Numbers: ORTHOGSURG01
Study First Received: March 21, 2012
Last Updated: March 21, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
clinical evaluation
controlled clinical trial
electromyography
exercise program
motor control

Additional relevant MeSH terms:
Malocclusion
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on November 20, 2014