Clinical Efficacy of Polynucleotides TMJ Injections Compared to Physiotherapy.

NCT ID: NCT06375330

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-18
• Study Completion Date: 2024-04-08

Brief 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.

Conditions

TMJ Disease; TMJ Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment

10 mg/ml Polynucleotides + 10 mg/ml Hyaluronic Acid in 2 mL prefilled syringe injections

Group Type: EXPERIMENTAL

PoliArt

Intervention Type: DEVICE

PoliArt injections

Physiotherapy

Physiotherapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PoliArt

PoliArt injections

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidoti & Tartaglia Srl

OTHER

Sponsor Role: lead

Responsible Party

Gianluca Tartaglia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gianluca Tartaglia, MD

Role: PRINCIPAL_INVESTIGATOR

ORDINARY PROFESSOR Department of Biomedical, Surgical and Dental Sciences

Locations

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

Milan, MI, Italy

Countries

Italy

Other Identifiers

Poli.01

Identifier Type: -

Identifier Source: org_study_id