An interventional study of Vitamin D3 (Cholecalciferol) and Normal Saline in Temporomandibular Joint Osteoarthritis, sponsored by Cairo University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to evaluate the efficacy of intra-articular Vitamin D3 injection for the treatment of temporomandibular joint (TMJ) osteoarthritis. The main questions it aims to answer are: is intra-articular Vitamin D3 injection more effective than placebo in the treatment of temporomandibular joint osteoarthritis? . Does it improve secondary clinical outcomes such as pain-free mouth opening and remove TMJ sounds? Researchers will compare Vitamin D3 to a normal saline placebo group to see if intra-articular Vitamin D3 provides therapeutic benefits. Participants will:Undergo a diagnostic evaluation including a questionnaire, clinical examination, and MRI. Receive a single intra-articular injection of either 1 ml of Vitamin D3 (Cholecalciferol 200,000 IU) or 1 ml of normal saline into the superior joint compartment. Attend follow-up visits at two weeks, three months, and six months to assess pain scores, mouth opening, and presence of tmj sound.
Temporomandibular joint (TMJ) osteoarthritis (OA) is characterized by the progressive destruction of the fibrocartilage layer, loss of protective synovial fluid, and accumulation of inflammatory mediators, leading to pain and functional impairment. This single-center, prospective, double-blind, randomized clinical trial investigates the therapeutic efficacy and safety of intra-articular Vitamin D3 (Cholecalciferol) versus a normal saline control. Following definitive diagnosis via MRI and preoperative clinical evaluation, patients undergo an auriculotemporal nerve block. The superior joint compartment (SJC) is check using an 18-gauge needle and a 10-ml syringe with normal Ringer solution through a repeated five-cycle injection-ejection process. Participants are allocated via a computer-generated randomization schedule managed by the main supervisor to ensure blinding of both the participants and the clinical assessor. The intervention arm receives an intra-articular injection of 1 ml of Vitamin D3 (Cholecalciferol 200,000 IU), while the control arm receives 1 ml of normal saline. Standardized post-operative care includes prescribed paracetamol, localized soft diet instructions for 48 hours, and avoidance of excessive functional loading. Data are evaluated across scheduled intervals up to six months post-injection to track clinical and mechanical joint parameters.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 26 is below the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Joint will be injected with 1ml of vitamin D3 ( Cholecalciferol 200.000 IU )
Drug: Vitamin D3 (Cholecalciferol)
Joint will be injected with 1ml of normal saline
Drug: Normal Saline
Single dose . joint will be injected with 1ml of Vitamin D3 ( Cholecalciferol 200.000 IU )
single dose . joint will be injected with 1ml of normal saline
Change from Baseline in Pain Intensity as Assessed by Visual Analogue Scale (VAS) at 6 Months
Time frame: 6 Months following end of treatment
Change from Baseline in Pain-Free Mouth Opening as Assessed by Caliper at 6 Months
Time frame: 6 Months following end of treatment
Change from Baseline in Temporomandibular Joint (TMJ) Sounds (Yes/No) at 6 Months
Time frame: 6 Months following end of treatment
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Cholecalciferol