NCT07445516 Occlusal Equilibration vs. Sham Therapies for TMDs: Post-Trial Follow-up (OEST)
| NCT ID | NCT07445516 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Urbano Santana Penin |
| Condition | Temporomandibular Disorders (TMD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2026-02-16 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 110 participants in total. It began in 2026-02-16 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
José López-Cedrún, Dr.
PRINCIPAL INVESTIGATOR
Complejo Hospitalario Universitario de A Coruña
Frequently Asked Questions
Who can join the NCT07445516 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Temporomandibular Disorders (TMD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07445516 currently recruiting?
Yes, NCT07445516 is actively recruiting participants. Contact the research team at urbano.santana@usc.es for enrollment information.
Where is the NCT07445516 trial being conducted?
This trial is being conducted at Santiago de Compostela, Spain, Santiago de Compostela, Spain.
Who is sponsoring the NCT07445516 clinical trial?
NCT07445516 is sponsored by Urbano Santana Penin. The principal investigator is José López-Cedrún, Dr. at Complejo Hospitalario Universitario de A Coruña. The trial plans to enroll 110 participants.