About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Previous occlusal equilibration for TMD pain at the University of Santiago.
Be diagnosed with joint and/or muscle TMD pain according to DC/TMD.
Be aged 18-85 years.
Be completely dentate with normal or adequately restored occlusion (fixed crowns/bridges allowed).
Disqualifiers
Psychosis, major depression, substance abuse, or cognitive impairment.
Opioid (morphine-derivative) addiction.
Ongoing litigation or disability claims related to chronic pain.
Dental professional background.
Trial population
All individuals previously treated with occlusal equilibration therapy at the University of Santiago de Compostela for chronic TMD pain who consent to undergo a follow-up diagnostic assessment will be eligible for inclusion. The subgroup that participated in the MAP clinical trial will be analyzed separately.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Group differences in change in pain intensity at 10 years follow-up in respect pretreatment scores.
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
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
"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.
Secondary outcomes
Psychological distress (GSI from SCL-90-R test)
SCL-90-R. Higher scores indicate greater psychological distress. The Global Severity Index (GSI) of the SCL-90-R ranges from 0 to 4. This index represents the mean score of all 90 items, each rated on a 0-4 Likert scale (0 = not at all, 4 = extremely). Thus, GSI values can vary between 0, indicating no symptoms, and 4, indicating maximum symptom severity.
Change in condylar path angles
Condylar path angles are meassured between the Franckfort horizontal plane and the condylar path recprdings
Sponsors and contacts
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Urbano Santana Penin
Lead sponsor
University of Santiago de Compostela
Sponsor institution