TMJ Disease, TMJ Pain
Conditions
Keywords
polynucleotides, TMJ, VAS, Physiotherapy, Hyaluronic acid, Laterality
Brief summary
The main objective of the present study is the evaluation of the clinical efficacy of the intra-articular administration of polynucleotides in association with hyaluronic acid in the improvement of the subjective and objective manifestations of arthrosis of the temporomandibular joint compared to normal clinical management which involves Physiotherapy.
Interventions
DEVICEPoliArt
PoliArt injections
Sponsors
Sidoti & Tartaglia Srl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients who signed the informed consent * age \>18; * male and female sex; * affected by temporomandibular arthrosis
Exclusion criteria
* Patients treated with painkillers and anti-inflammatories; * patients suffering from rheumatoid arthritis with TMJ involvement; * patients with a positive history of allergies to products of fish origin; * patients suffering from alteration of the internal TMJ; * patients suffering from mandibular condylar hyperplasia; * patients suffering from myofascial pain syndrome; * patients unable to express their consent for participation in the study; * patients suffering from psychiatric and behavioral disorders; * patients suffering from oncological and onco-haematological pathologies with compromised general clinical status.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum mouth opening | 3 months | The primary objective is to evaluate the improvement of symptoms over time in terms of maximum mouth opening of patients (which in most cases is limited) treated with polynucleotides in association with hyaluronic acid compared to patients treated with physiotherapy exercises. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lateral movements improvements | 3 months | Evaluation of the improvement of symptoms over time in terms of lateral movements in patients treated with polynucleotides in association with hyaluronic acid compared to patients treated with physiotherapy exercises. Lateral movements of the mandible were measured in millimeters as the distance between upper and lower midline at maximum lateral excursion; if the midlines were not centered at maximum intercuspation position, the midline shift in millimeters was added (if contralateral) or subtracted (if ipsilateral) to the recorded measurement. |
| Pain assessment | 3 months | Evaluation of the reduction of pain in the two groups over time with Visual Analogue Scale (VAS). VAS score was recorded on a Likert scale ranging from 1 to 10, according to the subjective pain felt by the patient. |
Countries
Italy
Outcome results
None listed