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Not yet recruiting NCT07129681

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

No phase Interventional TMJ Disc Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: dextrose 5%, Arthrocentesis/Saline.
Who it may be relevant to
Registry conditions: TMJ Disc Disorder. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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.

Overview

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.

Detailed description

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.

Interventions

  • Other 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
  • Other 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

Primary outcome measures

  • Change in Pain Severity Measured by Numerical Rating Scale (NRS) [Time frame: Measured at baseline, 3 days and 3 months after injection]
Secondary outcome measures (1)
  • Change in Maximal Interincisal Opening (MIO) Measured in Millimeters [Time frame: Measured at baseline, 3 days and 3 months after injection]

Eligibility criteria

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.

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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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

Identifiers

NCT: NCT07129681 · dextrose 5% injection in TMJ

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗