University of Bologna
Bologna, Emilia-Romagna, 40138, Italy
NCT Number: NCT03726060
The aim of study is evaluate the effectiveness of physical therapy in of the treatment myogenic temporomandibular disorders.
They will enrolled 100 patient which will be divided into two groups. The primary objective is evaluate the effectiveness of physiotherapy on pain (measured with the Visual Analogic Scale - VAS scale).
The second objective is evaluate mandibular motion (by measuring the range of motion - ROM) and investigate the presence of psychosocial factors (using the Anxiety and Depression Scale - HADS questionnaire).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Bologna, Emilia-Romagna, 40138, Italy
Randomized controlled clinical trial with randomization according to a multi-phase design.
Phase 1 involves the enrollment of patients with DTMs based on diagnostic criteria.
Phase 2 includes the algogenic, kinetic and gnathological evaluation of the enrolled patients.
Phase 3 provides for the adoption of the criterion to one of the 2 treatment groups on the basis of the randomization list.
The 2 therapeutic protocols are:
The code consists of a progressive number followed by the patient's initials (eg 01-F.R.).
Subsequently, the patients will be randomized blinded and assigned to one of the two study groups.
Randomization will be performed using random, computer-generated, centralized numbers placed in sealed opaque envelopes provided by the study coordinator.
Both types of treatment will be performed by a single operator respectively.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In the control group the patient will undergo gnathologic therapy for 6 months with neuromuscural splint every night for 3 months
Other names: splint therapy
In the test group the patient will undergo gnathologic therapy with neuromuscural splint every night for 3 months in association with physical therapy
Other names: splint therapy with physical therapy
Time frame: Change from initial VAS at 3 and 6 months from the beginning of the treatment
The VAS measures the intensity of the pain that thethe patient perceived and it is represented by a 10 cm long scale with a score from 0 to 10. The VAS will be evaluated in 3 times: at rest; during the maximum buccal opening; during chewing
Time frame: The measurement of the ROM occurs at the recruitment then at 3 and 6 months from the beginning of the treatment
The ROM measures the joint function. It provides the analytical and millimetric measurement of functional movements with a precision gauge positioned between the incisal edges of the upper and lower anterior groups.
It should be noted: maximum buccal opening; deviation of the median line; left and right lateral movements; overjet and overbite.
It should also be noted the extent of final elasticity (or end-feel test and its nature (elastic, painful, hard)
Paolo Pillastrini
Other
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