Clinical trial NCT03465033: Early Physiotherapy, Mandibular Motion and Sensorial Recovery After Orthognathic Surgery
Official title: Early Physiotherapy, Mandibular Motion and Sensorial Recovery After Orthognathic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mandibular Range of Motion
Pain
Sensorial Disturbance
Keywords: Orthognathic surgery
Jaw rehabilitation
Jaw Physiotherapy
Pain
Mandibular range of motion
Sensorial disturbance
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain during mandibular movements
timeFrame: week 12 (T4)
measure: Maximum interincisor opening
timeFrame: week 12 (T4)
Secondary outcomes:
measure: Lip symmetry
timeFrame: 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)
measure: Orofacial sensitivity
timeFrame: 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)
measure: Laterotrusion
timeFrame: 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)
measure: Protrusion
timeFrame: 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)
measure: Impact of the status of the oral function and structures on daily activities
timeFrame: Week 12 (T4)
measure: Functional oral movements - Gysi Gothic arch
timeFrame: After orthodontic removal: up to one year after OS (T6)
Other outcomes:
Locations:
city: Leioa
country: Spain
facility: Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country
state: Biscay
Study officials:
References:
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citation: Bell WH, Gonyea W, Finn RA, Storum KA, Johnston C, Throckmorton GS. Muscular rehabilitation after orthognathic surgery. Oral Surg Oral Med Oral Pathol. 1983 Sep;56(3):229-35. doi: 10.1016/0030-4220(83)90001-4.
citation: Bonine FL. Exercises to improve facial animation after orthognathic surgery. J Oral Maxillofac Surg. 1998 Feb;56(2):281. doi: 10.1016/s0278-2391(98)90898-9. No abstract available.
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citation: Gallerano G, Ruoppolo G, Silvestri A. Myofunctional and speech rehabilitation after orthodontic-surgical treatment of dento-maxillofacial dysgnathia. Prog Orthod. 2012 May;13(1):57-68. doi: 10.1016/j.pio.2011.08.002. Epub 2012 Jan 25.
citation: Hong SO, Baek SH, Choi JY. Physical Therapy for Smile Improvement After Orthognathic Surgery. J Craniofac Surg. 2017 Mar;28(2):422-426. doi: 10.1097/SCS.0000000000003099.
citation: Montero J, Bravo M, Albaladejo A. Validation of two complementary oral-health related quality of life indicators (OIDP and OSS 0-10 ) in two qualitatively distinct samples of the Spanish population. Health Qual Life Outcomes. 2008 Nov 18;6:101. doi: 10.1186/1477-7525-6-101.
citation: Phillips C, Kim SH, Tucker M, Turvey TA. Sensory retraining: burden in daily life related to altered sensation after orthognathic surgery, a randomized clinical trial. Orthod Craniofac Res. 2010 Aug;13(3):169-78. doi: 10.1111/j.1601-6343.2010.01493.x.
citation: Teng TT, Ko EW, Huang CS, Chen YR. The Effect of early physiotherapy on the recovery of mandibular function after orthognathic surgery for Class III correction: part I--jaw-motion analysis. J Craniomaxillofac Surg. 2015 Jan;43(1):131-7. doi: 10.1016/j.jcms.2014.10.025. Epub 2014 Nov 1.