Rehabilitative Management of Mastication

Phase 2

Completed

• Conditions: Surgery; Malocclusion
• Interventions: Other: counseling; Other: orofacial myofunctional treatment protocol; Other: Control Group

• Registration Number: NCT01562249
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2010-02
• Study Completion: 2011-10
• Status Verified: 2012-03
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-21
• Last Update Submitted: 2012-03-21
• Study First Posted: 2012-03-23
• Last Update Posted: 2012-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Instruction Group	counseling	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.
Experimental group	orofacial myofunctional treatment protocol	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.
Control group	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.

Primary Outcome Measures

Name	Time	Method
Evidence of clinical improvement in mastication after oral-motor rehabilitative program	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)

Trial Locations

Locations (1)

Hospital das Clinicas, University of São Paulo; 🇧🇷 São Paulo, Brazil