a Comparison of the Outcomes Following Intra-articular Dextrose 5% Injection Versus Arthrocentesis in Patients With Anterior Disc Displacement With Reduction of the Tomporomandibular Joint

Официальное название

A Comparison of the Outcomes Following Intra-articular Dextrose 5% Injection Versus Arthrocentesis in Patients With Anterior Disc Displacement With Reduction of the Temporomandibular Joint.

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое dextrose 5%
  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
• Другое Arthrocentesis/Saline
  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

Первичные конечные точки

• Change in Pain Severity Measured by Numerical Rating Scale (NRS) [Срок оценки: Measured at baseline, 3 days and 3 months after injection]

Вторичные конечные точки (1)

• Change in Maximal Interincisal Opening (MIO) Measured in Millimeters [Срок оценки: Measured at baseline, 3 days and 3 months after injection]

Критерии участия

Критерии включения

Критерии включения

-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.

• Age ranges from 18 to 50 years.
• Patients with adequate follow up duration for outcome assessment.

Критерии исключения

• Patients having pain or reduced mouth opening due to fracture of the condyle.
• patients having any degenerative changes in the TMJ.
• patients having other systemic diseases such as polyarthritis.
• patients having any neurological disorders.
• Pregnant and lactating women.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 33581954
• 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. PMID 26929478
• 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. PMID 28920043
• 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. PMID 26051574
• 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. PMID 30107954
• 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. PMID 36393924
• 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. PMID 32856082

Идентификаторы

NCT: NCT07129681 · dextrose 5% injection in TMJ

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗