NCT06375330

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

9 months

First QC Date

April 11, 2024

Last Update Submit

May 6, 2024

Conditions

TMJ DiseaseTMJ Pain

Keywords

polynucleotidesTMJVASPhysiotherapyHyaluronic acidLaterality

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Lateral movements improvements

    3 months

  • Pain assessment

    3 months

Study Arms (2)

Treatment

EXPERIMENTAL

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

Device: PoliArt

Physiotherapy

NO INTERVENTION

Physiotherapy

Interventions

PoliArtDEVICE

PoliArt injections

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who signed the informed consent
  • age \>18;
  • male and female sex;
  • affected by temporomandibular arthrosis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Milan, MI, 20122, Italy

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Gianluca Tartaglia, MD

    ORDINARY PROFESSOR Department of Biomedical, Surgical and Dental Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 11, 2024

First Posted

April 19, 2024

Study Start

April 18, 2023

Primary Completion

January 8, 2024

Study Completion

April 8, 2024

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)