Rehabilitative Management of Mastication

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562249
• Other study ID #: ORTHOGSURG01
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2012
• Last updated: March 21, 2012
• Start date: March 2009
• Est. completion date: October 2011

Study information

• Verified date: March 2012
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Malocclusion
• Surgery

Intervention

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.
• 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).
• 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.

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas, University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No