Redefining Clinical Trials on Regenerative Therapies to Target Responsiveness in Temporomandibular Joint Osteoarthritis Treatment.

Background: Temporomandibular joint osteoarthritis (TMJ-OA) presents a significant clinical challenge, marked by limited therapeutic options and variable patient responses. While regenerative therapies show promising results, conventional clinical trial methodologies often fail to demonstrate a significant clinical difference, largely due to response variabilities, which is critical in complex conditions like TMJ-OA. As such, methodologies traditionally used in clinical trials for regenerative therapies targeting TMJ-OA may need to be restructured to better identify and accommodate the distinctive profiles of responders and non-responders.

Objective: This paper proposes a revised clinical trial framework that focuses on differentiating responders from non-responders within treatment groups, rather than relying solely on traditional control groups.

Methods: Analysing non-responders provides valuable insights for therapeutic individualisation and optimises patient selection, as understanding predictive factors can lead to improved outcomes. We present recommendations that integrate imaging diagnostics, chronic pain characteristics, and psychosocial assessments, offering a novel approach to enhance efficacy of TMJ-OA treatment.

Conclusion: This work advocates for a re-evaluation of standard clinical trial designs to support more personalised and effective strategies for the management of TMJ-OA.