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Digital vs Conventional Stabilizing Splints in Temporomandibular Disorders

2026年4月27日 更新者:Aysha Sadaf、Shifa Tameer-e-Millat University

A Randomized Controlled Trial Comparing Digitally Fabricated and Conventional Stabilizing Splints in the Management of Temporomandibular Disorders

This randomized controlled trial aims to compare the clinical effectiveness of digitally fabricated and conventionally fabricated maxillary stabilization splints in patients diagnosed with Temporomandibular Disorders (TMD) according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).

Participants will be randomly allocated in a 1:1 ratio to receive either a Digitally fabricated splint produced using computer-aided design and three-dimensional printing technology or a conventionally fabricated splint using standard impression and laboratory techniques.

The primary outcome is Change in Pain Intensity measured using the Characteristic Pain Intensity component of the Graded Chronic Pain Scale (GCPS), 0-100 scale. Higher scores indicate greater pain severity from baseline to 3 months as primary end point.

Secondary outcomes include change in pain-related disability assessed using the Graded Chronic Pain Scale (GCPS) disability score, change in maximum mouth opening measured in millimeters (mm), change in jaw functional limitation assessed using the Jaw Functional Limitation Scale (JFLS), resolution of temporomandibular joint (TMJ) clicking (present/absent), change in oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14), and compliance with splint use measured as average nightly wear time (hours per night).

Assessments will be conducted at baseline and 3 months post-intervention. Outcome assessment will be performed by a blinded examiner.

研究概览

详细说明

This study is a parallel-group randomized controlled clinical trial designed to evaluate the effect of fabrication technique on the clinical performance of stabilization splints in patients with temporomandibular disorders (TMD). Eligible participants will be diagnosed according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I criteria. Following informed consent, participants will be randomly assigned in a 1:1 ratio to either the digitally fabricated splint group or the conventionally fabricated splint group using a computer-generated randomization sequence. Allocation concealment will be ensured by sequentially generated numbered, opaque, sealed envelopes prepared by an independent investigator.

For the digital workflow, maxillary and mandibular arches will be captured using an intra oral scanner. Splints will be designed using computer-aided design software and fabricated using additive manufacturing (three-dimensional printing) with biocompatible resin materials via digital light processing (DLP) technology. Post-processing will include cleaning and light curing according to standardized protocols.

For the conventional workflow, impressions will be obtained using elastomeric materials, followed by cast fabrication and articulation. Stabilization splints will be fabricated using heat-cured acrylic resin according to standardized laboratory procedures.

To ensure comparability between groups, splint design parameters will be standardized. All appliances will be maxillary full-coverage stabilization splints with even and simultaneous bilateral contacts in centric relation and canine-guided occlusion during excursive movements. Splint thickness will be standardized (approximately 2-3 mm), and all appliances will be adjusted intraorally at delivery to achieve uniform occlusal contacts.

Participants will be instructed to wear the splints nightly for a minimum of 8 hours. Clinical evaluations will be conducted at baseline and 3 months post-intervention. Outcome assessment will be performed by an examiner blinded to group allocation.

Data will be analyzed using IBM SPSS Statistics (version 26.0; IBM Corp., Armonk, NY, USA). A two-sided p-value < 0.05 will be considered statistically significant.. Normality will be assessed using the Shapiro-Wilk test. Between-group comparisons will be performed using independent t-tests or Mann-Whitney U tests, as appropriate. Within-group comparisons will be conducted using paired t-tests or Wilcoxon signed-rank tests. Repeated measures will be analyzed using repeated measures ANOVA or mixed-effects models.

This study is designed to isolate the effect of fabrication technique by controlling splint design variables while employing clinically relevant material systems, thereby providing evidence on the comparative effectiveness of digitally fabricated and conventionally fabricated stabilization splints in the management of temporomandibular disorders.

研究类型

介入性

注册 (估计的)

120

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Islamabad
      • Islamabad、Islamabad、巴基斯坦、2500
        • Shifa College Of Dentistry

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria

  • Adults aged 18-40 years
  • Diagnosis of Temporomandibular Disorder (TMD) according to standardized Diagnostic Criteria for Temporomandibular disorders Axis I
  • Maximum unassisted mouth opening between 20-30 mm
  • Symptoms present for ≥3 months (to exclude transient/self-limiting cases)
  • Willingness to comply with study protocol and provide informed consent

Exclusion Criteria

  • Diagnosis of temporomandibular joint myalgia or Myofascial pain as the primary condition
  • History of trauma to the temporomandibular joint or mandible
  • Presence of degenerative joint diseases (e.g., osteoarthritis, rheumatoid arthritis)
  • Congenital or developmental craniofacial anomalies affecting temporomandibular joint
  • Prior temporomandibular joint surgery or ongoing orthodontic treatment
  • Current use of: Analgesics, muscle relaxants, or anti-inflammatory drugs affecting temporomandibular joint symptoms
  • Prior Occlusal splint therapy within the last 3 months
  • Systemic conditions affecting joint function (e.g., connective tissue disorders)
  • Pregnancy or lactation (if intervention may influence compliance or physiology

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Conventional Stabilizing Splints Group

Participants allocated to this arm will receive conventionally fabricated maxillary stabilizing splints produced using traditional fabrication techniques. Maxillary and mandibular impressions will be obtained using elastomeric impression material, followed by cast fabrication in dental stone. Jaw relation will be recorded using a facebow transfer and centric relation registration. Splints will be fabricated on a semi-adjustable articulator using heat-cured acrylic resin. Occlusion will be adjusted to achieve even bilateral contacts in centric relation with canine-guided or mutually protected occlusion.

Participants will be instructed to wear the splint primarily during nighttime (minimum 8 hours daily). Necessary occlusal adjustments will be performed during follow-up visits.

A conventional stabilizing splint is a removable dental appliance that fits over the upper or lower teeth. It is made using traditional laboratory methods from heat cure acrylic material based on a standard impression of the patient's teeth.
实验性的:Digital Stabilizing Splints Group

Participants allocated to this arm will receive digitally fabricated maxillary stabilizing splints . Intra oral scanning will be performed to obtain digital impressions of both arches. Jaw relation will be recorded digitally transferred into the software. Splints will be designed using specialized Computer aided design software to ensure uniform thickness and precise occlusal contacts. Fabrication will be carried out using digital fabrication technology that is three dimensional printing with biocompatible resin material.

Post-insertion occlusal adjustments will be performed as needed to achieve even bilateral contacts in centric relation. Participants will be instructed to wear the splint primarily during nighttime (minimum 8 hours daily), similar to the conventional group.

A digital stabilizing splint is a removable appliance that fits over the teeth and is made using digital scanning and three dimensional printing technology. A digital scan of the patient's teeth is used to design the splint on a computer, and it is then fabricated using three dimensional printing technology using a biocompatible material.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Pain Intensity
大体时间:Baseline to 3 months post-intervention

Change in Pain intensity will be assessed using the Characteristic Pain Intensity (CPI) component of the Graded Chronic Pain Scale (GCPS). The CPI is calculated based on patient-reported current, worst, and average pain scores and is expressed on a 0-100 scale, where higher scores indicate greater pain intensity.

The outcome measure is the mean change in CPI score from baseline to 3 months post-intervention.

Baseline to 3 months post-intervention

次要结果测量

结果测量
措施说明
大体时间
Change in Pain-Related Disability
大体时间:Baseline to 3 months post-intervention
Change in Pain-related disability will be assessed using the disability component of the Graded Chronic Pain Scale (GCPS), which includes three items evaluating interference with daily activities, social activities, and work, each scored on a 0-10 scale. The mean of these items is multiplied by 10 to generate a disability score ranging from 0 to 100, where higher scores indicate greater disability. The outcome measure is the mean change in disability score from baseline to 3 months post-intervention.
Baseline to 3 months post-intervention
Change in maximum mouth opening (MMO)
大体时间:Baseline to 3 months post-intervention

Maximum mouth opening will be measured as the maximum unassisted inter-incisal distance (in millimeters) using a calibrated ruler or digital caliper. Measurements will be obtained under standardized conditions at each assessment visit.

The outcome measure is the mean change in MMO (mm) from baseline to 3 months post-intervention, where higher values indicate improved mandibular function.

Baseline to 3 months post-intervention
Change in Jaw Functional Limitation
大体时间:Baseline to 3 months post-intervention

Functional limitation will be assessed using the Jaw Functional Limitation Scale (JFLS-20), a validated patient-reported outcome measure consisting of 20 items evaluating mastication, vertical jaw mobility, and emotional and verbal expression. Each item is scored on a 0-10 scale, and the total score is calculated as the mean of all items, resulting in a score ranging from 0 to 10, where higher scores indicate greater functional limitation.

The outcome measure is the mean change in JFLS-20 score from baseline to 3 months post-intervention.

Baseline to 3 months post-intervention
Resolution of Temporomandibular joint (TMJ) clicking
大体时间:Baseline and 3 months post intervention

Resolution of TMJ clicking will be assessed clinically during mandibular opening and closing movements by a trained examiner under standardized conditions. Clicking will be recorded as a dichotomous variable (present/absent) based on the presence of an audible or palpable click during at least one of three consecutive mandibular opening-closing cycles.

The outcome measure is the proportion of participants demonstrating resolution of TMJ clicking (present at baseline and absent at 3 months post-intervention).

Baseline and 3 months post intervention
Change in oral health-related quality of life
大体时间:Baseline to 3 months post-intervention

Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14), a validated questionnaire consisting of 14 items evaluating functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Each item is scored on a 5-point Likert scale (0 = never to 4 = very often), with total scores ranging from 0 to 56, where higher scores indicate worse oral health-related quality of life.

The outcome measure is the mean change in OHIP-14 total score from baseline to 3 months post-intervention.

Baseline to 3 months post-intervention
Compliance with splint use
大体时间:From intervention (day of splint delivery) to 3 months post-intervention, with compliance recorded continuously and summarized as average nightly wear time at 3 months.

Compliance with splint use will be assessed based on patient-reported average nightly wear time (hours per night), recorded using a standardized daily log. Participants will document the number of hours the splint is worn each night throughout the study period.

The outcome measure is the mean average nightly wear time (hours/night) over the 3-month follow-up period.

From intervention (day of splint delivery) to 3 months post-intervention, with compliance recorded continuously and summarized as average nightly wear time at 3 months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Prof Anwar Ali Shah, BDS, PhD, M-Orth, FDSRCS、Shifa Tameer-e-Millat University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月1日

初级完成 (估计的)

2026年9月26日

研究完成 (估计的)

2026年10月26日

研究注册日期

首次提交

2026年3月16日

首先提交符合 QC 标准的

2026年4月27日

首次发布 (实际的)

2026年5月5日

研究记录更新

最后更新发布 (实际的)

2026年5月5日

上次提交的符合 QC 标准的更新

2026年4月27日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

De-identified individual participant data (IPD) underlying the results reported in this study, including baseline characteristics, outcome measures, and relevant covariates, will be made available. The study protocol and statistical analysis plan will also be shared.

IPD 共享时间框架

Data will be available from 6 months following publication to 2 years after publication.

IPD Start Date:

June 1, 2028

IPD End Date:

June 1, 2030

IPD 共享访问标准

Access to de-identified individual participant data (IPD), the study protocol, informed consent form, clinical study report and the statistical analysis plan will be granted to qualified researchers who submit a scientifically and methodologically sound research proposal. Requests will be reviewed by a committee comprising the principal investigator and an institutional research ethics representative.

Approved researchers will be provided access to the requested data through a secure, controlled-access institutional repository after execution of a data sharing agreement outlining conditions of use, data security requirements, and publication policy. All data will be shared in compliance with Shifa Tameer-e-Millat University ethical guidelines and applicable data protection regulations.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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