Actively Recruiting

Age: 18Years - 85Years
All Genders
NCT07445516

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

Led by Urbano Santana Penin · Updated on 2026-03-04

110

Participants Needed

2

Research Sites

27 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Previous occlusal equilibration for TMD pain at the University of Santiago
  • Diagnosed with joint and/or muscle TMD pain according to DC/TMD
  • Aged 18 to 85 years
  • Completely dentate with normal or adequately restored occlusion (fixed crowns/bridges allowed)
  • Reported pretreatment significant TMD pain (VAS/NRS 4-9 on a 0-10 scale)
  • Actively sought treatment and been referred to the University/Hospital service
  • Undergone at least 6 months of prior conservative therapy
Not Eligible

You will not qualify if you...

  • 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
  • Inability to achieve occlusal equilibration by minimally invasive adjustment due to specific jaw discrepancies measured intraorally

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Universidad de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain, 15782

Actively Recruiting

2

Urbano Santana Penín

Santiago de Compostela, A Coruña, Spain, 15782

Enrolling by Invitation

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Research Team

U

URBANO SANTANA PENIN, Prof.

CONTACT

M

Marcos Almeida Cerreda, Officer

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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