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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 10 mg/ml Polynucleotides + 10 mg/ml Hyaluronic Acid in 2 mL prefilled syringe injections |
|
| Physiotherapy | No Intervention | Physiotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PoliArt | Device | PoliArt injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum mouth opening | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lateral movements improvements | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianluca Tartaglia, MD | ORDINARY PROFESSOR Department of Biomedical, Surgical and Dental Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UOC di Chirurgia Maxillo-Facciale e Odontostomatologia della Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | MI | 20122 | Italy |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| 3 months |
| Pain assessment | 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. | 3 months |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |