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Rehabilitative Management of Mastication

U

University of Sao Paulo General Hospital

Status and phase

Completed
Phase 2

Conditions

Surgery
Malocclusion

Treatments

Other: Control Group
Other: orofacial myofunctional treatment protocol
Other: counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT01562249
ORTHOGSURG01

Details and patient eligibility

About

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

Full 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

Enrollment

17 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

17 participants in 3 patient groups

Experimental group
Experimental group
Description:
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.
Treatment:
Other: orofacial myofunctional treatment protocol
Instruction Group
Active Comparator group
Description:
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.
Treatment:
Other: counseling
Control group
No Intervention group
Description:
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.
Treatment:
Other: Control Group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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