Intra-articular Vitamin D3 Injection for Patients With Temporomandibular Joint Osteoarthritis
Temporomandibular Joint Osteoarthritis
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 26 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Patient with temporomandibular joint osteoarthritis according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), Axis I, Group III.b .
- Age ≥18
Exclusion Criteria:
- Previous TMJ surgery
- Specific osteoarthritis like rheumatoid arthritis or psoriatric arthritis.
- Pregnant women or breastfeeding ones
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Double masked
Group will be injected with Vitamin D3
Joint will be injected with 1ml of vitamin D3 ( Cholecalciferol 200.000 IU )
Drug: Vitamin D3 (Cholecalciferol)
Group will be injected with Normal Saline
Joint will be injected with 1ml of normal saline
Drug: Normal Saline
Vitamin D3 (Cholecalciferol) DRUG
Single dose . joint will be injected with 1ml of Vitamin D3 ( Cholecalciferol 200.000 IU )
Normal Saline DRUG
single dose . joint will be injected with 1ml of normal saline
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Change from Baseline in Pain Intensity as Assessed by Visual Analogue Scale (VAS) at 6 Months
Time frame: 6 Months following end of treatment
Not reported in this registry record.
Secondary measures
Change from Baseline in Pain-Free Mouth Opening as Assessed by Caliper at 6 Months
Time frame: 6 Months following end of treatment
Not reported in this registry record.
Change from Baseline in Temporomandibular Joint (TMJ) Sounds (Yes/No) at 6 Months
Time frame: 6 Months following end of treatment
Not reported in this registry record.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Faculty of oral and dental Medicine - cairo universityCairo, Cairo Governorate, EgyptStatus unknown
Study team and timeline
- Lead sponsor
- Cairo University
- Study start
- Jul 1, 2026 Actual
- Primary completion
- Jun 30, 2027 Estimated
- Study completion
- Jun 30, 2027 Estimated
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Efficacy of Intra-Articular Vitamin D3 Injection for Treatment of Temporomandibular Joint Osteoarthritis: A Randomized Clinical Trial
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026