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The Aim of this study is to evaluate the efficacy of intra-articular Dextrose injection with
concentration 5% in superior joint space of TMJ in comparison to arthrocentesis in patients with
anterior disc displacement with reduction of TMJ who did not respond favorably to conservative
treatment and to compare and infer which among the two procedures is more satisfactory,
whether dextrose 5% injection or Arthrocentesis.
The Aim of this study is to evaluate the efficacy of intra-articular Dextrose injection with
concentration 5% in superior joint space of TMJ in comparison to arthrocentesis in patients with
anterior disc displacement with reduction of TMJ who did not respond favorably to conservative
treatment and to compare and infer which among the two procedures is more satisfactory,
whether dextrose 5% injection or Arthrocentesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 patients with anterior disc displacement with reduction | Active Comparator |
| |
| Group 2 patients with anterior disc displacement of reduction | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dextrose 5% | Other | Dextrose, is an osmotic proliferant which acts by dehydrating the cells at the injection site which utlimately leads to release of cellular fragments that act as chemo attractants and start the inflammatory cascade leading todeposition of collagen |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Severity Measured by Numerical Rating Scale (NRS) | Primary Outcome Measure: 1. Change in Pain Severity Measured by Numerical Rating Scale (NRS) Pain severity will be assessed using the Numerical Rating Scale (NRS) (0-10), where 0 = no pain and 10 = severe pain. Participants will report their pain levels at each time point. The mean change in NRS scores from baseline will be calculated and analyzed . Data Aggregation: Mean change in NRS score | Measured at baseline, 3 days and 3 months after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Maximal Interincisal Opening (MIO) Measured in Millimeters | Maximal interincisal opening (MIO) will be measured using a sterilllized metal scale or a digital caliper, with values recorded in millimeters (mm). The mean change in MIO from baseline will be reported . Data Aggregation: Mean change in MIO (mm) with standard deviation (SD). | Measured at baseline, 3 days and 3 months after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Presence or Absence of Joint Clicking (Binary Outcome) | Joint clicking will be assessed as a binary outcome (Yes/No) based on clinical examination and patient-reported symptoms. The percentage of participants with joint clicking at each time point will be reported. Data Aggregation: Percentage of participants with joint clicking at each time point | Measured at baseline, 3 days and 3 months after injection |
Inclusion Criteria:
Inclusion Criteria
-Patients diagnosed with anterior disc displacement with reduction of TMJ with pain,limited mouth opening and
painful clicking who underwent conservative therapy with physiotherapy but failed to receive any relief after 3
months of conservative therapy.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandy Maged Ibrahim, bachelor's degree | Contact | +201149119389 | sandy.habib@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Moustafa Mohamed Talaat, Cairo assistant professor, PHD | Cairo University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33581954 | Background | Karadayi U, Gursoytrak B. Randomised controlled trial of arthrocentesis with or without PRF for internal derangement of the TMJ. J Craniomaxillofac Surg. 2021 May;49(5):362-367. doi: 10.1016/j.jcms.2021.01.018. Epub 2021 Feb 5. | |
| 26929478 | Background | Young AL. Internal derangements of the temporomandibular joint: A review of the anatomy, diagnosis, and management. J Indian Prosthodont Soc. 2015 Jan-Mar;15(1):2-7. doi: 10.4103/0972-4052.156998. |
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| Arthrocentesis/Saline | Other | Arthrocentesis , a highly successful, simple and minimally invasive procedure is a safe and simple method for treatment of anterior disc displacement with reduction of TMJ both in short term and long term follow up period, where it is a procedure of removing damaged tissues &inflammatory mediators.it can be the treatment modality for the for control group |
|
| 28920043 | Background | Maniquis-Smigel L, Dean Reeves K, Jeffrey Rosen H, Lyftogt J, Graham-Coleman C, Cheng AL, Rabago D. Short Term Analgesic Effects of 5% Dextrose Epidural Injections for Chronic Low Back Pain: A Randomized Controlled Trial. Anesth Pain Med. 2016 Dec 6;7(1):e42550. doi: 10.5812/aapm.42550. eCollection 2017 Feb. |
| 26051574 | Background | Rabago D, Mundt M, Zgierska A, Grettie J. Hypertonic dextrose injection (prolotherapy) for knee osteoarthritis: Long term outcomes. Complement Ther Med. 2015 Jun;23(3):388-95. doi: 10.1016/j.ctim.2015.04.003. Epub 2015 Apr 8. |
| 30107954 | Background | Fouda AA. Change of site of intra-articular injection of hypertonic dextrose resulted in different effects of treatment. Br J Oral Maxillofac Surg. 2018 Oct;56(8):715-718. doi: 10.1016/j.bjoms.2018.07.022. Epub 2018 Aug 11. |
| 36393924 | Background | Singh SU, Prasad RB, Punga R, Datta R, Singh N. A comparison of the outcomes following intra-articular steroid injection alone or arthrocentesis alone in the management of internal derangement of the temporomandibular joint. Natl J Maxillofac Surg. 2022 Aug;13(Suppl 1):S80-S84. doi: 10.4103/njms.njms_291_21. Epub 2022 Aug 20. |
| 32856082 | Background | Li TY, Chen SR, Shen YP, Chang CY, Su YC, Chen LC, Wu YT. Long-term outcome after perineural injection with 5% dextrose for carpal tunnel syndrome: a retrospective follow-up study. Rheumatology (Oxford). 2021 Feb 1;60(2):881-887. doi: 10.1093/rheumatology/keaa361. |
| ID | Term |
|---|---|
| D000069237 | Arthrocentesis |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D019152 | Paracentesis |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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