RecruitingNot Applicable

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

Spain110 participantsStarted 2026-02-16

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Group differences in change in pain intensity at 10 years follow-up in respect pretreatment scores.

Timeframe: Pretreatment, and 10 years follow-up

Group differences in the change in maximum unassisted mouth opening

Timeframe: pretreatment, 10 years follow-up

Odds of "success" in pain reduction of POOE compared with sham therapy

Timeframe: Pretreatmen, 10 years follow-up

Trial details

NCT IDNCT07445516

SponsorUrbano Santana Penin

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-30

Contact for this trial

URBANO SANTANA PENIN, Prof.

+ 34 647 344 093 urbano.santana@usc.es

View on ClinicalTrials.gov More Temporomandibular Disorders (TMD) trials