Clinical Efficacy of Polynucleotides TMJ Injections Compared to Physiotherapy.

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

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 Overview

• Status: Completed
• Conditions: TMJ Pain; TMJ Disease
• Intervention / Treatment: Device: PoliArt

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20122
      • UOC di Chirurgia Maxillo-Facciale e Odontostomatologia della Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; 10 mg/ml Polynucleotides + 10 mg/ml Hyaluronic Acid in 2 mL prefilled syringe injections	Device: PoliArt; PoliArt injections
No Intervention: Physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Sidoti & Tartaglia Srl
• Investigators: Principal Investigator: Gianluca Tartaglia, MD, ORDINARY PROFESSOR Department of Biomedical, Surgical and Dental Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2023
• Primary Completion (Actual): January 8, 2024
• Study Completion (Actual): April 8, 2024

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: VAS; Physiotherapy; Hyaluronic acid; TMJ; Laterality; polynucleotides
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Temporomandibular Joint Disorders
• Other Study ID Numbers: Poli.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No