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

NCT07445516 | Recruiting

• 1 other identifier: USC 124/2025
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 2

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.

Conditions

Temporomandibular Disorders (TMD); Myalgia of Mastication Muscle; Arthralgia Syndrome

Keywords

Occlusal Equilibration; Occlusal Adjustment; TemporoMandibular Disorders (TMD); Chronic Orofacial Pain; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (3)

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

  Differences between POOE and sham terapy groups in mean change in pain intensity at 10 years folloow-up, in respect pretreatment scores using VAS scale 0(no pain) to 10 (worst possible pain) . Greater differences indicate a better outcome.

  Pretreatment, and 10 years follow-up

• Group differences in the change in maximum unassisted mouth opening

  Distance between incissors during jaw opening using 0 to 60 mm TheraBite® range of motion scale™

  pretreatment, 10 years follow-up

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

  "Success" was defined as a decrease in pain scores ≥ 2 points while decreases \<2 points, as well as unmodified or increased pain scores were labeled as "failure". We also carried out an additional analysis in which we focused on strong effects of the treatment. In this additional analysis, we redefined success as a decrease in pain ≥ 4 points, and any other effect as "failure". It will be adjusted for third covariables in order to remove any confounding bias.

  Pretreatmen, 10 years follow-up

Secondary Outcomes (2)

• Psychological distress (GSI from SCL-90-R test)

  Pretreatment, 10 years follow-up

• Change in condylar path angles

  Pretreatment, 10 years follow-up

Study Arms (2)

Physilogically Oriented Occlusal Equilibration (POOE) Therapy

Occlusal equilibration to recover physiological jaw closure and alternate chewing function

Sham therapy

Simulation (placebo) of occlusal equilibration therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All individuals previously treated with occlusal equilibration therapy at the University of Santiago de Compostela for chronic TMD pain who consent to undergo a follow-up diagnostic assessment will be eligible for inclusion. The subgroup that participated in the MAP clinical trial will be analyzed separately.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Urbano Santana Penin: lead

Study Sites (2)

Universidad de Santiago de Compostela

Santiago de Compostela, A Coruña, 15782, Spain

RECRUITING

Urbano Santana Penín

Santiago de Compostela, A Coruña, 15782, Spain

ENROLLING BY INVITATION

Related Publications (3)

• Santana-Mora U, Lopez-Cedrun J, Mora MJ, Otero XL, Santana-Penin U. Temporomandibular disorders: the habitual chewing side syndrome. PLoS One. 2013 Apr 8;8(4):e59980. doi: 10.1371/journal.pone.0059980. Print 2013.

  PMID: 23593156 BACKGROUND

• Santana-Mora U, Lopez-Cedrun J, Suarez-Quintanilla J, Varela-Centelles P, Mora MJ, Da Silva JL, Figueiredo-Costa F, Santana-Penin U. Asymmetry of dental or joint anatomy or impaired chewing function contribute to chronic temporomandibular joint disorders. Ann Anat. 2021 Nov;238:151793. doi: 10.1016/j.aanat.2021.151793. Epub 2021 Jun 26.

  PMID: 34186201 RESULT

• Santana-Penin U, Santana-Mora U, Lopez-Solache A, Mora MJ, Collier T, Pocock SJ, Lorenzo-Franco F, Varela-Centelles P, Lopez-Cedrun JL. Remodeling dental anatomy vs sham therapy for chronic temporomandibular disorders. A placebo-controlled randomized clinical trial. Ann Anat. 2023 Oct;250:152117. doi: 10.1016/j.aanat.2023.152117. Epub 2023 Jun 9.

  PMID: 37302432 RESULT

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• José López-Cedrún, Dr.

  Complejo Hospitalario Universitario de A Coruña

  PRINCIPAL INVESTIGATOR

Central Study Contacts

URBANO SANTANA PENIN, Prof.

CONTACT

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

Marcos Almeida Cerreda, Officer

CONTACT

+34 881 811 000; dpd@usc.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Emeritus

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: March 3, 2026
• Study Start: February 16, 2026
• Primary Completion: June 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

ES (2)