Occlusal Equilibration vs. Sham Therapies for TMDs: Post-Trial Follow-up (OEST)
RecruitingNCT07445516
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- OEST Protocol: Physiologically Oriented Occlusal Equilibration Versus Sham Therapy for Chronic Temporomandibular Disorders (TMDs): 10 Years Post-trial Follow-up
- Conditions
- Temporomandibular Disorders (TMD)
- Myalgia of Mastication Muscle
- Arthralgia Syndrome
- Sponsor
- Urbano Santana Penin
- Organization
- University of Santiago de Compostela
- Start date
- 2026-02-16
- Primary completion
- 2026-06-30
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- Spain
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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). * Report pretreatment significant TMD pain (VAS/NRS 4-9 on a 0-10 scale). * Have actively sought treatment and been referred to the University/Hospital service. * Have undergone ≥6 months of prior conservative therapy. Exclusion Criteria: * Psychosis, major depression, substance abuse, or cognitive impairment. * Opioid (morphine-derivative) addiction. * Ongoing litigation or disability claims related to chronic pain. * Dental professional background. * Orthodontic treatment within the last 2 years. * Severe tooth mobility (grade 3). * Other pain conditions indistinguishable from or more severe than TMD pain. * Additionally, patients will be excluded if minimally invasive occlusal adjustment cannot achieve equilibration, defined by: 2 mm discrepancy between maximal intercuspation and centric occlusion, and/or 4 mm total interarch discrepancy (≥2 mm on one side) in defined premolar/molars reference points, measured intraorally using a Boley gauge.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07445516