Occlusal Equilibration vs. Sham Therapies for TMDs: Post-Trial Follow-up (OEST)

Condition(s) studied

Study summary

Chronic temporomandibular disorders (TMDs) affect the masticatory muscles, the temporomandibular joints (TMJs), and associated structures. Except in cases of trauma, their etiology remains uncertain, debated, and multifactorial. Conservative therapies-including no active intervention-often alleviate symptoms; however, approximately 3% of the population develops persistent forms associated with substantial individual suffering and significant social and economic burden.

At the Unit of Occlusion and Prosthodontics of the University of Santiago de Compostela (USC), Physiologically Oriented Occlusal Equilibration (POOE) has been used for chronic painful TMDs since 1985. POOE aims to correct unilateral mastication patterns and to establish appropriate non-working side contacts in order to protect the temporomandibular joints from mechanical overload. Singh (Cochrane, 2024) emphasized that occlusal interventions should be evaluated with long-term follow-up of at least 3-5 years.

This is a single-blind study: the evaluator remains blinded to treatment allocation during outcome assessment. The aim of this observational study is to assess the long-term effectiveness of POOE treatments for chronic TMDs from 1985 to the present. Treatment effectiveness will be confirmed if the reduction in pain achieved with POOE is statistically significant and clinically meaningful (≥1.5/10 on a 0-10 visual analog scale) compared with sham therapy at ≥3 years post-intervention relative to baseline. Additionally, effectiveness will be supported if the proportion of individuals meeting criteria for chronic TMD ("affected") is lower in the POOE-treated group than in those receiving alternative therapies.

Eligibility

Primary outcome measure(s)

• Group differences in change in pain intensity at 10 years follow-up in respect pretreatment scores. — Pretreatment, and 10 years follow-up
  Differences between POOE and sham terapy groups in mean change in pain intensity at 10 years folloow-up, in respect pretreatment scores using VAS scale 0(no pain) to 10 (worst possible pain) . Greater differences indicate a better outcome.
• Group differences in the change in maximum unassisted mouth opening — pretreatment, 10 years follow-up
  Distance between incissors during jaw opening using 0 to 60 mm TheraBite® range of motion scale™
• Odds of "success" in pain reduction of POOE compared with sham therapy — Pretreatmen, 10 years follow-up
  "Success" was defined as a decrease in pain scores ≥ 2 points while decreases \<2 points, as well as unmodified or increased pain scores were labeled as "failure". We also carried out an additional analysis in which we focused on strong effects of the treatment. In this additional analysis, we redefined success as a decrease in pain ≥ 4 points, and any other effect as "failure". It will be adjusted for third covariables in order to remove any confounding bias.

Trial sites (2)

Other trials for the same condition