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Clinical Efficacy of Polynucleotides TMJ Injections Compared to Physiotherapy.

S

Sidoti & Tartaglia Srl

Status

Completed

Conditions

TMJ Disease
TMJ Pain

Treatments

Device: PoliArt

Study type

Interventional

Funder types

Other

Identifiers

NCT06375330
Poli.01

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Treatment
Experimental group
Description:
10 mg/ml Polynucleotides + 10 mg/ml Hyaluronic Acid in 2 mL prefilled syringe injections
Treatment:
Device: PoliArt
Physiotherapy
No Intervention group
Description:
Physiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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