Temporomandibular joint disorders Digestive System
Conditions
Interventions
This study investigates whether a broad-spectrum nutraceutical treatment is as effective as short-term therapy for temporomandibular disorders (TMDs).
Computer-generated randomization will be undertak
No treatment (Control Group Ia). In case of ongoing occlusal splint therapy, patients will be enrolled in: Treatment with Neutraceutical and splint therapy (Neutraceutical + Splint Group – Group II)
Treatment with occlusal splint only (Control Group IIa).
The participants are blinded to group assignments. Participants will be told that they have an equal chance of being assigned to one of the t
Sponsors
Sapienza University of Rome
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Presence of dysfunctions of the craniocervical musculature, in the presence or absence of parafunction 2. Presence of muscular pain at the level of the masseter of the medium-high entity with a minimum value of 40 and a maximum of 100 according to the VNS (verbal numerical scale), spontaneous and/or investigated by palpatory manoeuvres 3. Presence of arthralgia in at least one temporomandibular joint 4. Presence of the following comorbidities such as headache attributed to temporomandibular disorders, cervicalgia 5. Presence of sleep disturbances (no OSAS) and emotional factors (stress and anxiety) investigated with a nominal scale (presence or absence) 6. Patients waiting for or undergoing conservative gnathological therapy
Exclusion criteria
Exclusion criteria: 1. Psychiatric pathologies 2. Systemic pathologies with disease-related muscular impairment 3. Pain therapy or myorelaxant medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intensity of temporomandibular disorder pain measured using the Verbal Numerical Scale (VNS) at T0 ( before treatment) and T1 (after treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement of quality of life relating to physical disabilities measured using the Verbal-Numerical Scale (VNS) to report the severity, if present, of comorbidities, such as headache and neck pain and presence/absence of sleep/emotional disturbances (only with a dichotomic classification yes/no) at T0 and T1 2. Analysis of mandibular function (presence of articular noises, evaluation of functional excursions and maximum mouth opening) and palpatory examination were also recorded at T0 and T1 | — |
Countries
Italy
Contacts
Public ContactPaola Di Giacomo
Outcome results
None listed