Mandibular Range of Motion, Pain, Sensorial Disturbance
Conditions
Keywords
Orthognathic surgery, Jaw rehabilitation, Jaw Physiotherapy, Pain, Mandibular range of motion, Sensorial disturbance
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.
Interventions
OTHEREarly Physiotherapy
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.
Sponsors
University of the Basque Country (UPV/EHU)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. |
| 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. |
Countries
Spain
Contacts
Primary ContactRafael Martinez-Conde, MD
Backup ContactJoana Laña, BS
Outcome results
None listed