Trials / Completed
CompletedNCT01562249
Rehabilitative Management of Mastication
Rehabilitative Management of Mastication After Orthognathic Surgery: A Randomized Controlled Trial
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- University of Sao Paulo General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to verify the effectiveness of a systematic rehabilitative program for mastication in patients submitted to orthognathic surgery.
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 | 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 | 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. |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2010-02-01
- Completion
- 2011-10-01
- First posted
- 2012-03-23
- Last updated
- 2012-03-23
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT01562249. Inclusion in this directory is not an endorsement.