Occlusal equilibration versus sham therapies for long-term relief of temporomandibular disorder pain — post‑trial follow‑up
OEST Protocol: Physiologically Oriented Occlusal Equilibration Versus Sham Therapy for Chronic Temporomandibular Disorders (TMDs): 10 Years Post-trial Follow-up
This follow-up tests whether a bite‑adjustment procedure called physiologically oriented occlusal equilibration provides lasting pain relief for adults who previously had chronic TMD and were treated at the University of Santiago de Compostela.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Santiago de Compostela Academic / other |
| Locations | 2 sites (Santiago de Compostela, A Coruña and 1 other locations) |
| Trial ID | NCT07445516 on ClinicalTrials.gov |
What this trial studies
This observational long‑term follow‑up contacts patients who previously underwent physiologically oriented occlusal equilibration (POOE) or sham therapies at the University of Santiago de Compostela to document pain outcomes over several years. Eligible participants were adults diagnosed with muscle and/or joint TMD according to DC/TMD, fully dentate or adequately restored, with moderate pretreatment pain and prior conservative care. The protocol collects long‑term pain intensity measures (original baseline, 6‑month results, and multiple‑year follow‑up) to determine whether initial benefits persist. Standard exclusion criteria (major psychiatric disease, opioid addiction, recent orthodontics, severe tooth mobility, indistinguishable other pain conditions, active litigation) limit confounding and select for typical chronic TMD patients treated at this center.
Who should consider this trial
Good fit: Adults aged 18–85 with DC/TMD‑diagnosed muscle or joint pain who previously received occlusal equilibration at the University of Santiago de Compostela, are fully dentate or have adequately restored occlusion, and had moderate pretreatment pain (VAS/NRS 4–9).
Not a fit: Patients with major psychiatric disorders, opioid addiction, recent orthodontic treatment, severe tooth mobility, other indistinguishable dominant pain conditions, ongoing litigation, or those who were not treated at the USC occlusion unit are unlikely to gain from this specific follow‑up evaluation.
Why it matters
Potential benefit: If positive, the follow‑up could show that occlusal equilibration produces durable, years‑long reductions in TMD pain for some patients.
How similar studies have performed: Previous randomized work showed POOE was more effective than placebo at 6 months, but long‑term effectiveness beyond 3–5 years remains uncertain and is the main gap this follow‑up addresses.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Santiago de Compostela, A Coruña and 1 other locations
- Universidad de Santiago de Compostela — Santiago de Compostela, A Coruña, Spain (Recruiting)
- Urbano Santana Penín — Santiago de Compostela, A Coruña, Spain (Enrolling_by_invitation)
Study contacts
- Principal investigator: José López-Cedrún, Dr. — Complejo Hospitalario Universitario de A Coruña
- Study coordinator: URBANO SANTANA PENIN, Prof.
- Email: urbano.santana@usc.es
- Phone: + 34 647 344 093
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.