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Completed

NCT Number: NCT06375330

Clinical Efficacy of Polynucleotides TMJ Injections Compared to Physiotherapy.

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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Key information

Conditions

TMJ Disease Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases TMJ Pain Temporomandibular Joint Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UOC di Chirurgia Maxillo-Facciale e Odontostomatologia della Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PoliArt

Device

PoliArt injections

Primary outcomes

  1. Maximum mouth opening

    Time frame: 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 outcomes

  1. Lateral movements improvements

    Time frame: 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.

  2. Pain assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sidoti & Tartaglia Srl

Other

Registry information

Official study title

Clinical Efficacy of Polynucleotides TMJ Injections Compared to Physiotherapy. A 3-months Randomized Clinical Trial.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2024
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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