Temporomandibular Disorders (TMD)OESTNCT07445516
Occlusal Equilibration vs. Sham Therapies for TMDs: Post-Trial Follow-up (OEST)
An observational study of Temporomandibular Disorders (TMD) and Myalgia of Mastication Muscle, run by Urbano Santana Penin at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Temporomandibular Disorders (TMD), Myalgia of Mastication Muscle, Arthralgia Syndrome
- How many people
- 110 participants
- Where
- 2 sitesSpain
- Study dates
- 16 Feb 2026to 30 Aug 2026
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Universidad de Santiago de Compostela
Santiago de Compostela, A Coruña, 15782
URBANO SANTANA PENIN, Prof., 647344093, urbano.santana@usc.es
- Enrolling by invitation
Urbano Santana Penín
Santiago de Compostela, A Coruña, 15782
About this study
Official title: OEST Protocol: Physiologically Oriented Occlusal Equilibration Versus Sham Therapy for Chronic Temporomandibular Disorders (TMDs): 10 Years Post-trial Follow-up
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.
Read the detailed description
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.
- Keywords
- Occlusal Equilibration, Occlusal Adjustment, TemporoMandibular Disorders (TMD), Chronic Orofacial Pain, Randomized Clinical Trial
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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™
Measured: 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.
Measured: Pretreatmen, 10 years follow-up
Secondary outcomes (2)
Psychological distress (GSI from SCL-90-R test)
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.
Measured: Pretreatment, 10 years follow-up
Change in condylar path angles
Condylar path angles are meassured between the Franckfort horizontal plane and the condylar path recprdings
Measured: Pretreatment, 10 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start16 Feb 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Urbano Santana Penin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Urbano Santana Penin, University of Santiago de Compostela
- Investigators
- José López-Cedrún, Dr., Principal investigator, Complejo Hospitalario Universitario de A Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445516
- Sponsor's protocol ID
- USC 124/2025
- Other IDs
- USC 124/2025
- Acronym
- OEST
- Status last verified
- Mar 2026
- First submitted
- 17 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23593156Santana-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.
PubMed 34186201Santana-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.
PubMed 37302432
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OEST Protocol: Physiologically Oriented Occlusal Equilibration Versus Sham Therapy for Chronic Temporomandibular Disorders (TMDs): 10 Years Post-trial Follow-up
- ClinicalTrials.gov ID
- NCT07445516
- Acronym / sponsor ID
- OEST / USC 124/2025
- Keywords
- Occlusal Equilibration, Occlusal Adjustment, TemporoMandibular Disorders (TMD), Chronic Orofacial Pain, Randomized Clinical Trial
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Urbano Santana PeninUniversity, hospital or other
- Study start
- 16 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 20 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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™
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.
2 secondary outcomes
Psychological distress (GSI from SCL-90-R test)
Time frame: Pretreatment, 10 years follow-up
Change in condylar path angles
Time frame: Pretreatment, 10 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 23593156Santana-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.
- Results publication: PubMed 34186201Santana-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.
- Results publication: PubMed 37302432Santana-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
José López-Cedrún, Dr. principal investigator
Complejo Hospitalario Universitario de A Coruña
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorders (TMD) and Myalgia of Mastication Muscle, run by Urbano Santana Penin at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact URBANO SANTANA PENIN, Prof. (+ 34 647 344 093, urbano.santana@usc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group differences in change in pain intensity at 10 years follow-up in respect pretreatment scores. (time frame: Pretreatment, and 10 years follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07445516, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.