Injection into the temporomandibular joint by the traditional way and the guided way

A randomized clinical study of the accuracy of intra-temporomandibular joint injections combining non-guided injection with ultrasound-guided injection, with a comparison of the procedure and therapeutic efficacy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN23008770

Enrollment

Registered

2024-07-16

Start date

2023-01-30

Completion date

Unknown

Last updated

2024-07-29

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

Conditions

Temporomandibular joint disorders Oral Health

Interventions

Participants were randomly allocated by drawing cards to non-guided injection or ultrasound-guided injection. Platelet-rich plasma (PRP) was injected with contrast medium Ominpque 350 mg and the mixt

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who complain of at least one of the following: joint pain, joint pain, or decreased mouth opening 2. Healthy patients who do not have general diseases that affect healing 3. Patients who have not had their temporomandibular joint treated surgically 4. Aged 18-60 years 5. There is no infection at the injection site 6. Insensitivity to the components of the injection 7. There are no kidney diseases affecting the indication for contrast media

Exclusion criteria

Exclusion criteria: 1. Injection site infection during follow-up periods 2. Patients receiving long-term dental treatment or whose joint area was affected by unusual trauma during the follow-up period 3. Patient's non-compliance with follow-ups 4. The presence of advanced joint problems that require surgical treatment, category IV and V, according to Dimitroulis G (2013)

Design outcomes

Primary

Measure	Time frame
1. Accuracy of the injected mixture location measured using CBCT imaging just after the mixture is delivered 2. Maximum mouth opening measured in millimeters at baseline, after 1 week, 1 month, and 3 months 3. Pain caused by tissue penetration measured using visual analogue score (VAS) at rest mandibular position 12, 24 and 48 hours after injection 4. Pain when chewing measured using VAS at 12, 24 and 48 hours after injection 5. Pain on TMJ palpation measured using VAS before injection and after 1 week, 1 and 3 months 6. Presence of joint sounds measured using auscultation and palpation before injection, after 1 week, 1 and 3 months	—

Measure

Time frame

1. Accuracy of the injected mixture location measured using CBCT imaging just after the mixture is delivered 2. Maximum mouth opening measured in millimeters at baseline, after 1 week, 1 month, and 3 months 3. Pain caused by tissue penetration measured using visual analogue score (VAS) at rest mandibular position 12, 24 and 48 hours after injection 4. Pain when chewing measured using VAS at 12, 24 and 48 hours after injection 5. Pain on TMJ palpation measured using VAS before injection and after 1 week, 1 and 3 months 6. Presence of joint sounds measured using auscultation and palpation before injection, after 1 week, 1 and 3 months

—

Secondary

Measure	Time frame
Optimal PRP and iodinated contrast agent mixture ratio for TMJ CBCT arthrography, determined using CBCT imaging and questionnaire (this part of the study was done before the main part that involved 24 samples, aiming to find the appropriate mixture for use in the primary objectives of the study)	—

Countries

Syria

Contacts

Public ContactAsaad Shehada

asaad9.shehada@damascusuniversity.edu.sy+963 (0)994556568

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026