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NCT Number: NCT07445516

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain

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About this study

Chronic TMDs constitute a complex syndrome that is currently understood as comprising more than 30 distinct nosological entities. The underlying cause of their pathophysiology has not been fully elucidated. Consequently, treatments are typically empirical and applied simultaneously, including pharmacotherapy, counseling, physiotherapy, occlusal splints (perhaps the most widely used), physical modalities, and other minimally invasive procedures such as arthrocentesis or arthroscopy, extending even to total TMJ replacement. None of these interventions has demonstrated superior efficacy compared with placebo or no treatment. Globally, these patients often consult multiple specialists and undergo numerous treatment modalities, with an unpredictable prognosis.

Physiologically oriented occlusal equilibration (POOE) was shown to be more effective than placebo at 6 months post-treatment. The 2024 Cochrane review indicated that assessing the efficacy of occlusal therapies requires evaluation at least 3 to 5 years after treatment. The treatments performed at USC since 1985 for chronic TMDs represent a valuable source of long-term clinical experience that may clarify whether POOE remains effective many years after treatment (from 1985 to the present), rather than only at 6 months.

Scientific Objectives To evaluate the effect of occlusal adjustment on pain intensity in patients with chronic TMDs during long-term follow-up over several years.

To disseminate the findings-whether positive, negative, or inconclusive-in peer-reviewed scientific journals.

Methods This is an observational study, as no intervention will be applied to participants. It will be open-label or single-blind (outcome assessors will be blinded to the treatment previously received, but participants will not be). The study is cross-sectional, as it will be conducted at a single time point and in a single visit. The study will consist of diagnosing any current TMDs potentially affecting individuals who were previously treated at USC for chronic TMDs. All participating individuals are familiar with the diagnostic procedures, which include extra- and intraoral examination, dynamic recording of mandibular and condylar movements, and the tests recommended in the DC/TMD criteria.

If the participant provides authorization, clinically relevant information from their medical record regarding TMD history will be used to determine the degree of improvement or deterioration relative to the pretreatment baseline.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: Pretreatment, and 10 years follow-up

    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.

  2. Group differences in the change in maximum unassisted mouth opening

    Time frame: pretreatment, 10 years follow-up

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

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

    Time frame: Pretreatmen, 10 years follow-up

    "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.

Secondary outcomes

  1. Psychological distress (GSI from SCL-90-R test)

    Time frame: Pretreatment, 10 years follow-up

    SCL-90-R. Higher scores indicate greater psychological distress. The Global Severity Index (GSI) of the SCL-90-R ranges from 0 to 4. This index represents the mean score of all 90 items, each rated on a 0-4 Likert scale (0 = not at all, 4 = extremely). Thus, GSI values can vary between 0, indicating no symptoms, and 4, indicating maximum symptom severity.

  2. Change in condylar path angles

    Time frame: Pretreatment, 10 years follow-up

    Condylar path angles are meassured between the Franckfort horizontal plane and the condylar path recprdings

Study contacts

Contact information is provided by the study sponsor or research team.

Marcos Almeida Cerreda, Officer

CONTACT

[email protected]

+34 881 811 000

URBANO SANTANA PENIN, Prof.

CONTACT

[email protected]

+ 34 647 344 093

Sponsors and collaborators

Lead sponsor

Urbano Santana Penin

Other

Registry information

Official study title

OEST Protocol: Physiologically Oriented Occlusal Equilibration Versus Sham Therapy for Chronic Temporomandibular Disorders (TMDs): 10 Years Post-trial Follow-up

Acronym: OEST

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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