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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06375330
Other study ID # Poli.01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 18, 2023
Est. completion date April 8, 2024

Study information

Verified date May 2024
Source Sidoti & Tartaglia Srl
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 8, 2024
Est. primary completion date January 8, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
PoliArt
PoliArt injections

Locations

Country Name City State
Italy UOC di Chirurgia Maxillo-Facciale e Odontostomatologia della Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan MI

Sponsors (1)

Lead Sponsor Collaborator
Sidoti & Tartaglia Srl

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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.
3 months
Secondary 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
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