Clinical Efficacy of Polynucleotides TMJ Injections Compared to Physiotherapy.

TMJ Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06375330
• Other study ID #: Poli.01
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Temporomandibular Joint Disorders
• TMJ Disease
• TMJ Pain

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