OEST Protocol: Physiologically Oriented Occlusal Equilibration Versus Sham Therapy for Chronic Temporomandibular Disorders (TMDs): 10 Years Post-trial Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Group differences in change in pain intensity at 10 years follow-up in respect pretreatment scores.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
结局指标
主要结局
Group differences in change in pain intensity at 10 years follow-up in respect pretreatment scores.
时间窗: 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.
Odds of "success" in pain reduction of POOE compared with sham therapy
时间窗: 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.
Group differences in the change in maximum unassisted mouth opening
时间窗: pretreatment, 10 years follow-up
Distance between incissors during jaw opening using 0 to 60 mm TheraBite® range of motion scale™
次要结局
- Psychological distress (GSI from SCL-90-R test)(Pretreatment, 10 years follow-up)
- Change in condylar path angles(Pretreatment, 10 years follow-up)
研究者
Urbano Santana Penin
Professor Emeritus
University of Santiago de Compostela