TMJ DiseaseNCT06375330
Clinical Efficacy of Polynucleotides TMJ Injections Compared to Physiotherapy.
A study testing PoliArt in people with TMJ Disease and TMJ Pain, run by Sidoti & Tartaglia Srl at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TMJ Disease, TMJ Pain
- What is being tested?
- PoliArt
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 18 Apr 2023to 8 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who signed the informed consent
- age >18;
- male and female sex;
- affected by temporomandibular arthrosis
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
UOC di Chirurgia Maxillo-Facciale e Odontostomatologia della Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, MI, 20122
About this study
Official title: 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.
- Conditions
- TMJ Disease, TMJ Pain
- Being tested
- PoliArt
- Keywords
- polynucleotides, TMJ, VAS, Physiotherapy, Hyaluronic acid, Laterality
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PoliArtDevice
PoliArt injections
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 10 mg/ml Polynucleotides + 10 mg/ml Hyaluronic Acid in 2 mL prefilled syringe injections Receives: Device: PoliArt |
| Physiotherapy | No intervention | Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start18 Apr 2023
- Primary completion8 Jan 2024
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidoti & Tartaglia Srl
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Tartaglia, Sidoti & Tartaglia Srl
- Investigators
- Gianluca Tartaglia, MD, Principal investigator, ORDINARY PROFESSOR Department of Biomedical, Surgical and Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375330
- Sponsor's protocol ID
- Poli.01
- Status last verified
- May 2024
- First submitted
- 11 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Polynucleotides TMJ Injections Compared to Physiotherapy. A 3-months Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06375330
- Acronym / sponsor ID
- Poli.01
- Conditions
- TMJ Disease, TMJ Pain
- Keywords
- polynucleotides, TMJ, VAS, Physiotherapy, Hyaluronic acid, Laterality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sidoti & Tartaglia SrlUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: PoliArt10 mg/ml Polynucleotides + 10 mg/ml Hyaluronic Acid in 2 mL prefilled syringe injections |
| Physiotherapy | No intervention | –Physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients who signed the informed consent
- age >18;
- male and female sex;
- affected by temporomandibular arthrosis
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PoliArtPoliArt injections | Device | Treatment |
Primary outcome
Maximum mouth opening
Time frame: 3 months
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.
2 secondary outcomes
Lateral movements improvements
Time frame: 3 months
Pain assessment
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianluca Tartaglia, MD principal investigator
ORDINARY PROFESSOR Department of Biomedical, Surgical and Dental Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PoliArt in people with TMJ Disease and TMJ Pain, run by Sidoti & Tartaglia Srl at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum mouth opening (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.