Clinical Efficacy of Polynucleotides TMJ Injections Compared to Physiotherapy.

Sidoti & Tartaglia Srl60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

TMJ Disease TMJ Pain

Interventions

PoliArtDEVICE

PoliArt injections

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Milan, MI, Italy

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 3 months

Data from ClinicalTrials.gov

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