TMJ
Arthroscope-Guided Intra-Articular Injection of Chitosan-Hyaluronate Gel Mixture Versus Hyaluronic Acid in the Treatment of TMJ Internal Derangement: A Randomized Controlled Clinical Trial
Sponsor study identifier
interventional
20
1 country
1
Study Start
January 17, 2024
Actual (reported)Primary Completion
June 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study is designed to assess the impact of injecting sodium hyaluronic acid versus a chitosan-hyaluronate hybrid gel into the upper compartment of the temporomandibular joint (TMJ) as a treatment for anterior disc displacement without reduction. The study will include patients diagnosed with Stage III or IV TMJ internal derangement (anterior disc displacement without reduction), as classified by Wilkes, with diagnoses confirmed through clinical symptoms and MRI evaluations. Participants will be randomly divided into two groups, both undergoing TMJ arthroscopy. In the first group, 2 ml of chitosan-hyaluronic acid hybrid gel will be injected into the affected joints, whereas in the second group, 2 ml of hyaluronic acid (HA) will be administered. The study will compare and analyze outcomes in both groups, focusing on pain during TMJ function, clicking sounds, the extent of maximum mouth opening, and maximum lateral jaw movement.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 17, 2024
Actual (reported)May 12, 2024
Actual (reported)May 23, 2024
Actual (reported)June 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Joint Pain
Self-pain and function of the jaw assessment, with Visual Analogue Scale (VAS), ranging from 0 to 10 scales. This scale will be used for self-evaluation of the patients, to evaluate pain level and jaw dysfunction and compared with preoperative degree. Patients will be asked about the pain severity \& dysfunction according to the VAS.
3 months
lateral excursion
Maximum lateral excursion, the distance from midline of upper \& lower jaw will be measured with a digital caliper in mm.
3 months
TMJ sounds
measured by asking the patients to open and closed his mouth several times and clicking was recorded as present (early clicking, late clicking) or absent.
3 months
Maximum mouth opening
Maximum mouth opening (MMO), between upper \& lower incisors will be measured during maximum opening with a digital caliber in mm.
Arthroscope-guided intra-articular injection of Hyaluronic Acid in patients with TMJ anterior disc displacement without reduction.
Arthroscope-guided intra-articular injection of chitosan-hyaluronate gel mixture in patients with TMJ anterior disc displacement without reduction
The operation will be under GA. TMJ arthroscopy will performed by the same TMJ arthroscopy surgeon. Lysis and lavage will be performed in the upper joint space in all cases based on the triangulation technique with an inferolateral approach. The arthroscopic procedure will include lysis of adhesions, lavage, manipulation, and debridement of the upper joint space. A 1.9-mm arthroscope with a video monitoring and recording system and a 2.2-mm protective cannula sheath will be used for TMJ arthroscopy. Ringer's lactate will be used as irrigation fluid. Both groups will receive the same arthroscopic treatments. The injection of 2 ml of Chitosan-Hyaluronate Gel Mixture into affected joints will be performed. Needles will be removed after the injection sites and covered its sites with gauze dressing.
Suez University
Suez, 41522, Egypt
Elfarmawy MA, Al-Saadi AAA, Alkhatib MH, Alsaadi MA, Shobair NI. Arthroscope-guided intra-articular injection of chitosan-hyaluronate gel mixture vs hyaluronic acid in the treatment of temporomandibular joint internal derangement: a randomized controlled clinical trial. Int J Oral Maxillofac Surg. 2026 Apr 27:S0901-5027(26)00149-9. doi: 10.1016/j.ijom.2026.04.008. Online ahead of print.
First Submitted
May 12, 2024
First Posted
May 23, 2024
Study Start
January 17, 2024
Actual (reported)Primary Completion
June 1, 2024
Estimated (date passed)3 months
The operation will be under GA. TMJ arthroscopy will performed by the same TMJ arthroscopy surgeon. Lysis and lavage will be performed in the upper joint space in all cases based on the triangulation technique with an inferolateral approach. The arthroscopic procedure will include lysis of adhesions, lavage, manipulation, and debridement of the upper joint space. A 1.9-mm arthroscope with a video monitoring and recording system and a 2.2-mm protective cannula sheath will be used for TMJ arthroscopy. Ringer's lactate will be used as irrigation fluid. Both groups will receive the same arthroscopic treatments. The injection of 2 ml of Hyaluronic acid into affected joints will be performed. Needles will be removed after the injection sites and covered its sites with gauze dressing.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 23, 2024
Record last verified: 2024-01
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