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Completed

NCT Number: NCT01562249

Rehabilitative Management of Mastication

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

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Key information

Conditions

Surgery Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital das Clinicas, University of São Paulo

São Paulo, 05403-000, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

orofacial myofunctional treatment protocol

Other

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 names: rehabilitative orofacial myofunctional protocol

Counseling

Other

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 names: supervised instruction

Control Group

Other

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

Primary outcomes

  1. Evidence of clinical improvement in mastication after oral-motor rehabilitative program

    Time frame: within the first year after surgery (plus or minus 2 weeks)

    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)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

Rehabilitative Management of Mastication After Orthognathic Surgery: A Randomized Controlled Trial

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Mar 23, 2012
Registry last updated
Mar 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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