Early Physiotherapy, Mandibular Motion and Sensorial Recovery After Orthognathic Surgery

Study Overview
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Brief Summary
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Several studies describe that the maximum mandibular opening decreases 60% -70% immediately after orthognathic surgery (OS) and other variables, including laterotrusion, movement speed and facial mimic also decrease drastically. In addition, patients frequently experience temporary or permanent sensory orofacial disturbances ranging from 9% to 76% of cases. It has been described that scheduled early physiotherapy reduces these complications.

Detailed Description
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Before the surgical intervention (T0) the maximum interincisal oral opening measurement, laterotrusion and maximum protrusion will be recorded by digital caliber. The overbite and the overjet, length of upper lip and lower facial third will be measured. The symmetry of the upper lip in a forced smile will be determined. The measurements made at T0 will be repeated at T1 (2 weeks after surgery), T2 (5 weeks after surgery), T3 (9 weeks after surgery), T4 (12 weeks after surgery), T5 (24 weeks after surgery) and T6 (after orthodontic removal).The level of pain during the measurements of the mandibular movements will be recorded in the Visual Analogue Scale, and the self-reported area of the orofacial sensory alterations by means of a diagram and the objective area by means of the sensory discrimination test of two points will be determined. In T4, the impact of the status of the function and oral structures on daily activities will be recorded through a self-pass questionnaire based on the Oral Index Daily Performance questionnaire (OIDP-sp). In the T6 the measurement of laterotrusion, protrusion and retrusion movements measured by Gysi Gothic arch will be performed.

Official Title
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Early Physiotherapy, Mandibular Motion and Sensorial Recovery After Orthognathic Surgery

Conditions
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Mandibular Range of Motion, Pain, Sensorial Disturbance

Intervention / Treatment
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* Other: Early Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years Patients treated with orthodontics and OS for correction of dentofacial deformities. Exclusion Criteria: Patients diagnosed with temporomandibular disorders Patients diagnosed with orofacial pain Patients diagnosed with orofacial sensory alterations Patients not treated with orthodontics Patients and who need to undergo OS interventions for the treatment of Sleep Apnea-Hypopnea Syndrome Patients that present cleft palate Patients that present cleft lip Patients diagnosed with syndromes that affect the orofacial structures.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients undergoing OS will be studied. All patients will be told that two interventions are compared but they will not know which one is the usual care or the early physiotherapy. All of them will receive instructions of basic care after surgery: use of intermaxillary elastics, soft diet during the first month and semi-soft during the second month. Patients will be asked to remove the intermaxillary elastics 30min before the measurements.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Patients will receive basic indications of rehabilitation consisting of daily mobilization of the jaw (perform several movements a day opening movements, laterotrusion and mouth protrusion). | |
| Experimental: Early Physiotherapy<br> | Other: Early Physiotherapy<br>* From T1 to T2 patients will perform 3 daily repetitions of active exercises:1 5 repetitions of oral opening exercises and bilateral manual progressive stretching, protrusion and maximum lateralization of the jaw on both sides, holding each movement for 5s and a session of cryotherapy applied to the masseter, temporal and suprahyoid muscles for 120s in two 60s sessions. They will also perform 30 repetitions of exercises aimed at improving the labial seal (inflate cheeks) and the symmetry of the upper lip (broad smile). From T2 to T3 30 repetitions of the same exercises will be performed and passive progressive opening will be implemented by clamping Patients will also perform isometric contraction exercises in opening, closing, laterotrusion, protrusion and retrusion. Each movement will be repeated 5 times and it will remain for 5s.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during mandibular movements | The level of pain during the measurements of the mandibular movements will be registered using a Visual Analogue Scale, in which point 0 represents no pain and point 10 maximum pain. Values under point 5 are considered to represent mild pain and values above point 5 severe pain | week 12 (T4) | 
| Maximum interincisor opening | The maximum interincisal oral opening measurement will be recorded by digital caliber | week 12 (T4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lip symmetry | Lip symmetry will be recorded by facial photography of the patient in broad smile | Before OS (T0), week 2 after surgery (T1), week 5 (T2), week 9 (T3), week 12 (T4), week 24 (T5), and after orthodontic removal: up to one year after OS (T6) | 
| Orofacial sensitivity | Self-reported area of orofacial sensory alterations will be measured by means of a diagram and the objective area by means of the sensory discrimination test of two points. | Week 2 after surgery (T1), week 5 (T2), week 9 (T3), week 12 (T4), week 24 (T5), and after orthodontic removal: up to one year after OS (T6) | 
| Laterotrusion | The oral laterotrusion measurement will be recorded by digital caliber | Before OS (T0), week 2 after surgery (T1), week 5 (T2), week 9 (T3), week 12 (T4), week 24 (T5), and after orthodontic removal: up to one year after OS (T6) | 
| Protrusion | The oral protrusion measurement will be recorded by digital caliber | Before OS (T0), week 2 after surgery (T1), week 5 (T2), week 9 (T3), week 12 (T4), week 24 (T5), and after orthodontic removal: up to one year after OS (T6) | 
| Impact of the status of the oral function and structures on daily activities | The impact of the status of the oral function and structures on daily activities will be recorded through a self-pass questionnaire based on the Oral Index Daily Performance questionnaire (OIDP-sp)). In the OIDP index impacts are quantified by multiplying the frequency and severity scores to obtain the performance score for each of eight dimensions (eating, speaking, cleaning teeth, working, social relation, sleeping/relaxing, smiling and emotional status). The sum of these scores is considered the total impact score. This total score is divided by the maximum possible score and multiplied by 100 to give the percentage score. This scoring system yields an intuitive oral impact score. | Week 12 (T4) | 
| Functional oral movements - Gysi Gothic arch | The measurement of laterotrusion, protrusion and retrusion movements measured by Gysi Gothic arch will be performed and the functional oral movements capacity will be measured bay the total of millimeters of all movements | After orthodontic removal: up to one year after OS (T6) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthognathic surgery, Jaw rehabilitation, Jaw Physiotherapy, Pain, Mandibular range of motion, Sensorial disturbance