Injections to treat problems in the jaw joint

Injections for the treatment of articular temporomandibular disorders

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-6dvfcwd

Enrollment

552

Registered

2026-07-10

Start date

2023-04-24

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthralgia

Interventions

This study consists of a randomized double blind clinical trial including participants with unilateral or bilateral articular temporomandibular disorders, with a diagnosis of arthralgia without joint

Eligibility

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients aged 18 to 65 years; both sexes; patients screened among those registered for care at the Multidisciplinary Center for Orofacial Pain of the Federal University of Santa Catarina; diagnosis of articular temporomandibular disorder according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD); symptoms of articular temporomandibular disorder including arthralgia, osteoarthritis, osteoarthrosis or articular disc displacement with or without reduction for at least 1 week

Exclusion criteria

Exclusion criteria: Patients younger than 18 years of age; continuous use of analgesics or anti inflammatory drugs; pregnancy; cardiovascular diseases; psychiatric disorders; blood dyscrasias; trigeminal neuralgia; history of odontogenic infectious diseases within the previous 30 days; neoplasia or radiotherapy in the head and neck region within the previous 5 years; local infection of the temporomandibular joint; glucose 6 phosphate dehydrogenase deficiency; hyperthyroidism; hypertension; myasthenia gravis

Design outcomes

Primary

Measure	Time frame
Expected outcome 1: It is expected to observe a reduction in temporomandibular joint pain intensity after intra articular infiltrations, assessed using the 11 point Numeric Rating Scale, in which 0 indicates no pain and 10 indicates the worst pain imaginable, with assessments at baseline, before each treatment session and at the 1 month and 4 month follow up evaluations;Observed outcome 1: A reduction in temporomandibular joint pain intensity was observed over the follow up period in the completed and analyzed substudy, involving 21 participants and 42 temporomandibular joints randomized to ozone or saline solution. Significant reductions were observed at 1 month and 4 months compared with baseline in both groups, with no statistically significant difference between ozone and saline solution at the same follow up periods	—

Measure

Time frame

Expected outcome 1: It is expected to observe a reduction in temporomandibular joint pain intensity after intra articular infiltrations, assessed using the 11 point Numeric Rating Scale, in which 0 indicates no pain and 10 indicates the worst pain imaginable, with assessments at baseline, before each treatment session and at the 1 month and 4 month follow up evaluations;Observed outcome 1: A reduction in temporomandibular joint pain intensity was observed over the follow up period in the completed and analyzed substudy, involving 21 participants and 42 temporomandibular joints randomized to ozone or saline solution. Significant reductions were observed at 1 month and 4 months compared with baseline in both groups, with no statistically significant difference between ozone and saline solution at the same follow up periods

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Secondary

Measure	Time frame
Expected outcome 10: It is expected to observe differences in clinical response among the intra articular interventions planned in the general protocol, including ozone, corticosteroid, sodium hyaluronate, placebo, ozone combined with sodium hyaluronate and placebo combined with sodium hyaluronate, assessed through pain intensity, pressure pain threshold, mandibular function, joint sounds, otologic symptoms and patient reported outcomes during follow up;Expected outcome 2: It is expected to observe changes in somatosensory function after intra articular infiltrations, assessed through mechanical pain tests including wind up ratio, pressure pain threshold and conditioned pain modulation in the temporomandibular joint region and thenar muscle at baseline and at the 1 month and 4 month follow up evaluations;Observed outcome 2: No statistically significant differences were observed in the completed and analyzed substudy for somatosensory outcomes, including wind up ratio, pressure pain threshold and conditioned pain modulation in the temporomandibular joint region or thenar muscle, either over time or between ozone and saline solution;Expected outcome 3: It is expected to observe changes in psychosocial and chronic pain related outcomes after intra articular infiltrations, assessed using the Depression Anxiety and Stress Scale 21, Pain Catastrophizing Scale and Graded Chronic Pain Scale at baseline and during follow up;Observed outcome 3: No statistically significant differences were observed in Depression Anxiety and Stress Scale 21 scores for anxiety, depression or stress in the completed and analyzed substudy. Statistically significant differences were observed between baseline and the 4 month follow up for Pain Catastrophizing Scale and Graded Chronic Pain Scale, with a change from high pain intensity and low disability to low pain intensity and low disability during follow up;Expected outcome 4: It is expected to observe a reduction in joint sound intensity after i	—

Measure

Time frame

Expected outcome 10: It is expected to observe differences in clinical response among the intra articular interventions planned in the general protocol, including ozone, corticosteroid, sodium hyaluronate, placebo, ozone combined with sodium hyaluronate and placebo combined with sodium hyaluronate, assessed through pain intensity, pressure pain threshold, mandibular function, joint sounds, otologic symptoms and patient reported outcomes during follow up;Expected outcome 2: It is expected to observe changes in somatosensory function after intra articular infiltrations, assessed through mechanical pain tests including wind up ratio, pressure pain threshold and conditioned pain modulation in the temporomandibular joint region and thenar muscle at baseline and at the 1 month and 4 month follow up evaluations;Observed outcome 2: No statistically significant differences were observed in the completed and analyzed substudy for somatosensory outcomes, including wind up ratio, pressure pain threshold and conditioned pain modulation in the temporomandibular joint region or thenar muscle, either over time or between ozone and saline solution;Expected outcome 3: It is expected to observe changes in psychosocial and chronic pain related outcomes after intra articular infiltrations, assessed using the Depression Anxiety and Stress Scale 21, Pain Catastrophizing Scale and Graded Chronic Pain Scale at baseline and during follow up;Observed outcome 3: No statistically significant differences were observed in Depression Anxiety and Stress Scale 21 scores for anxiety, depression or stress in the completed and analyzed substudy. Statistically significant differences were observed between baseline and the 4 month follow up for Pain Catastrophizing Scale and Graded Chronic Pain Scale, with a change from high pain intensity and low disability to low pain intensity and low disability during follow up;Expected outcome 4: It is expected to observe a reduction in joint sound intensity after i

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Countries

Contacts

Public ContactBeatriz Mendes de Souza

Universidade Federal de Santa Catarina

profabeatrizmendes@gmail.com+55(48)3721-4952

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Aug 10, 2026