Early Physiotherapy, Mandibular Motion and Sensorial Recovery After Orthognathic Surgery
- Conditions
- PainSensorial DisturbanceMandibular Range of Motion
- Interventions
- Other: Early Physiotherapy
- Registration Number
- NCT03465033
- Lead Sponsor
- University of the Basque Country (UPV/EHU)
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- ≥18 years
- Patients treated with orthodontics and OS for correction of dentofacial deformities.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early Physiotherapy Early Physiotherapy -
- Primary Outcome Measures
Name Time Method Pain during mandibular movements 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 week 12 (T4) The maximum interincisal oral opening measurement will be recorded by digital caliber
- Secondary Outcome Measures
Name Time Method 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) Lip symmetry will be recorded by facial photography of the patient in broad smile
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) 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.
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) The oral laterotrusion measurement will be recorded by digital caliber
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) The oral protrusion measurement will be recorded by digital caliber
Impact of the status of the oral function and structures on daily activities Week 12 (T4) 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.
Functional oral movements - Gysi Gothic arch After orthodontic removal: up to one year after OS (T6) 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
Trial Locations
- Locations (1)
Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country
🇪🇸Leioa, Biscay, Spain