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

Not Applicable

Completed

• Conditions: Temporomandibular joint disorders; Oral Health

• Registration Number: ISRCTN23008770
• Lead Sponsor: Damascus University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-04-30
• Study Start: 2024-07-16
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)