跳至主要内容
临床试验/NCT07640035
NCT07640035尚未招募1 期

Objective Assessment of Bruxism and Treatment Response Using Digital Occlusal Analysis: A Clinical Study of Botulinum Toxin-A

Bilecik Seyh Edebali Universitesi1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年7月20日最近更新:
适应症

试验速览

阶段
1 期
状态
尚未招募
入组人数
36
试验地点
1

研究概览

简要总结

Bruxism is a repetitive jaw-muscle activity that may lead to tooth wear, muscle pain, headaches, and functional limitations. Current diagnostic approaches mainly rely on self-reported symptoms and clinical examination findings, which may not accurately reflect ongoing muscle activity. Digital occlusal analysis systems offer an objective method for evaluating bite force and occlusal function.

The aim of this randomized, placebo-controlled clinical trial is to investigate whether a digital occlusal analysis system can objectively assess bruxism and monitor treatment response following Botulinum Toxin-A (BTX-A) injections. Thirty-six adults diagnosed with bruxism will be randomly assigned to receive either BTX-A injections or placebo injections into the masseter muscles.

Clinical examinations, patient-reported outcomes, and digital occlusal measurements will be collected at baseline and at 2 weeks, 3 months, and 6 months after treatment. Primary outcomes include bite force characteristics, force distribution, occlusion time, disocclusion time, and center of force. Secondary outcomes include pain intensity, maximum mouth opening, muscle tenderness, functional limitation scores, and self-reported bruxism-related symptoms.

This study aims to provide objective evidence regarding the usefulness of digital occlusal analysis in the diagnosis and follow-up of bruxism and to evaluate the effectiveness of Botulinum Toxin-A treatment using both objective and subjective outcome measures.

详细描述

Bruxism is a repetitive jaw-muscle activity characterized by clenching and/or grinding of the teeth and is associated with various oral and craniofacial consequences, including tooth wear, muscle pain, headaches, and temporomandibular disorders. Recent international consensus statements define bruxism as a motor behavior rather than a disease entity, emphasizing the need for multidimensional assessment approaches.

Current diagnostic methods primarily rely on self-reported symptoms and clinical findings. However, self-reports may be affected by recall bias and limited awareness, while clinical signs often reflect cumulative tissue changes rather than ongoing functional activity. Although electromyography and polysomnography can provide objective information regarding masticatory muscle activity, their routine clinical use is limited by cost, technical complexity, and accessibility.

Digital occlusal analysis systems have emerged as promising tools for the objective evaluation of occlusal force characteristics. These technologies allow quantitative assessment of bite force distribution, occlusal timing, and force balance, potentially providing indirect information about masticatory muscle function. Despite their increasing clinical use, the role of digital occlusal analysis systems in the diagnosis and longitudinal monitoring of bruxism remains insufficiently investigated.

Botulinum Toxin-A (BTX-A) has been increasingly used for the management of bruxism because of its ability to reduce masticatory muscle activity through inhibition of acetylcholine release at the neuromuscular junction. Previous studies have demonstrated reductions in bite force and symptom severity following BTX-A treatment. However, most available studies have focused on subjective outcomes or lacked placebo-controlled designs and objective functional measurements.

This study was designed to address these gaps by investigating whether digital occlusal analysis can serve as an objective tool for evaluating bruxism and monitoring therapeutic response. The findings may contribute to the development of more objective diagnostic and follow-up strategies for bruxism while providing additional evidence regarding the functional effects of Botulinum Toxin-A treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors responsible for clinical examinations and digital occlusal analysis measurements will be blinded to treatment allocation. The clinician administering the injections will not be blinded due to the nature of the intervention.

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years and older
  • Diagnosis of bruxism based on self-report and clinical assessment
  • Systemically healthy individuals
  • Angle Class I occlusion
  • Ability and willingness to provide written informed consent and comply with study procedures

排除标准

  • Presence of temporomandibular joint pathology
  • Neuromuscular disorders
  • Pregnancy or lactation
  • Known allergy or hypersensitivity to Botulinum Toxin-A
  • Use of medications that may affect muscle function
  • Missing posterior teeth
  • Ongoing orthodontic treatment
  • Angle Class II or Class III malocclusion
  • Previous Botulinum Toxin injection into the masseter muscles

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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