Early Physiotherapy, Mandibular Motion and Sensorial Recovery After Orthognathic Surgery
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Pain during mandibular movements
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
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. Professionals that will evaluate the measurements and the investigators that will make the statistical analysis, all will be blinded to treatment allocation.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Early Physiotherapy
Intervention: Early Physiotherapy (Other)
Usual Care
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).
Outcomes
Primary Outcomes
Pain during mandibular movements
Time Frame: week 12 (T4)
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
Maximum interincisor opening
Time Frame: week 12 (T4)
The maximum interincisal oral opening measurement will be recorded by digital caliber
Secondary Outcomes
- Lip symmetry(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(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(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(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(Week 12 (T4))
- Functional oral movements - Gysi Gothic arch(After orthodontic removal: up to one year after OS (T6))
Investigators
Rafael Martínez-Conde Llamosas
Principal Investigator
University of the Basque Country (UPV/EHU)