Injection of Adipose-Derived Mesenchymal Stem Cell-Enriched Adipose Extract for Temporomandibular Joint Osteoarthritis: A Randomised Controlled Trial.

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Aims: This study aims to compare the efficacy of adipose-derived mesenchymal stem cells-enriched adipose extract (ARDE) with hyaluronic acid (HA) intra-articular injection in the treatment of temporomandibular joint osteoarthritis.Methods: The randomised controlled trial included patients who did not respond to conservative treatment, were diagnosed with anterior disc displacement without reduction according to the diagnostic criteria for Temporomandibular Disorders, and had a Visual Analogue Scale (VAS) score >4. After joint lavage, the control group received HA injections, while the study group received ARDE injections. The primary outcome included VAS scores for pain, while secondary outcome measures included maximum mouth opening (MMO) and magnetic resonance imaging results. Evaluations were performed at baseline, 1 month, and 6 months postoperatively.Results: A total of 50 patients were enrolled (25 per group), with comparable baseline characteristics between groups (P > .05). Analysis of covariance showed that the least-squares (LS) mean change in VAS score from baseline to month 6 in the ARDE vs HA groups was -4.9 vs -4.3 cm, respectively (LS mean difference, -0.7; 95% CI, -1.1 to -0.2; P = .009). For the MMO, the LS mean change was 1.7 vs 1.4 cm, respectively (LS mean difference, 0.3; 95% CI, 0 to 0.5; P = .022). Linear mixed-effects models verified significant group and time main effects for VAS score (both P < .001) and significant group main effect for MMO (P = .009), but no significant group-by-time interaction was found for either indicator (both P > .05). Magnetic resonance imaging indicated more significant resolution of preoperative joint effusion in ARDE group (18/22 vs 6/20, P < .01).Conclusion: ARDE injections demonstrate promising potential in relieving pain and improving joint function in patients with temporomandibular joint osteoarthritis, as compared with HA injections.