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

NCT07129681 | Not Yet Recruiting

• 1 other identifier: dextrose 5% injection in TMJ
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

TMJ Disc Disorder

Keywords

TMJ; Disc displacement with reduction; Dextrose 5%; Arthrocentesis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in Maximal Interincisal Opening (MIO) Measured in Millimeters

  Measured at baseline, 3 days and 3 months after injection

Other Outcomes (1)

• Presence or Absence of Joint Clicking (Binary Outcome)

  Measured at baseline, 3 days and 3 months after injection

Study Arms (2)

Group 1 patients with anterior disc displacement with reduction

ACTIVE COMPARATOR

Other: dextrose 5%

Group 2 patients with anterior disc displacement of reduction

EXPERIMENTAL

Other: Arthrocentesis/Saline

Interventions

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

Group 1 patients with anterior disc displacement with reduction

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

Group 2 patients with anterior disc displacement of reduction

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (7)

• 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 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.

  PMID: 26929478 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.

  PMID: 28920043 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.

  PMID: 26051574 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.

  PMID: 30107954 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.

  PMID: 36393924 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.

  PMID: 32856082 BACKGROUND

MeSH Terms

Interventions

Arthrocentesis; Sodium Chloride

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Moustafa Mohamed Talaat, Cairo assistant professor, PHD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Sandy Maged Ibrahim, bachelor's degree

CONTACT

+201149119389; sandy.habib@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: sandy Maged Habib Ibrahim

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: August 19, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share