Vertical Facial Morphology and Occlusal Force Changes After Masseter Botulinum Toxin Injection in Bruxism
2026年6月23日 更新者：Fatma Macit、Biruni University
Influence of Vertical Facial Morphology on Occlusal Force Changes After Masseter Botulinum Toxin Injection in Bruxism: A Prospective T-Scan Study
This study investigated whether the shape of the face affects how jaw muscles respond to botulinum toxin injections in people who grind their teeth (bruxism).
Participants were divided into two groups based on their facial structure: low-angle (shorter face height) and normal-angle.
Each participant received botulinum toxin type A injections into the masseter (jaw) muscle.
Bite force measurements were taken before and 15 days after the injection using the T-Scan computerized occlusal analysis system.
The study aimed to determine whether facial structure influences the early changes in bite force balance following the injection.
研究概览
研究类型
介入性
注册 (实际的)
34
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
-
-
Istanbul
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Istanbul、Istanbul、土耳其（türkiye）、34010
- Department of Orthodontics, Faculty of Dentistry, Biruni University
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-
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:
- Age 18-40 years
- Confirmed bruxism diagnosis through self-report and clinical signs
- Full permanent dentition excluding third molars
- Angle Class I molar relationship
- No previous BTX-A injection within 6 months
- GoGn/SN angle between 18° and 38° on lateral cephalometric radiograph
Exclusion Criteria:
- Systemic neuromuscular disorders
- Known allergy to botulinum toxin or its excipients
- Pregnancy or breastfeeding
- Active infection at the injection site
- Concurrent use of medications known to interact with BTX-A
- History of orthognathic surgery or prior temporomandibular joint surgery
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：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Masseter BTX-A Injection (Low-Angle and Normal-Angle Subgroups)
Patients with bruxism received bilateral masseter muscle injections of 25 units of botulinum toxin type A (Botox®, Allergan) per side.
T-Scan occlusal force measurements were performed at baseline (T0) and day 15 post-injection (T1).
Participants were stratified into low-angle and normal-angle subgroups based on GoGn/SN cephalometric angle.
|
Botulinum toxin type A (Botox®, Allergan, Irvine, CA, USA) was injected bilaterally into the masseter muscle at a dose of 25 units per side (50 units total per patient).
Injections were performed by a single experienced clinician under sterile conditions using a 30-gauge needle.
其他名称：
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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 Center of Force (CoF)
大体时间：Baseline (T0) and day 15 post-injection (T1)
|
The Center of Force (CoF) represents the geometric center of the total occlusal force distribution, measured using the T-Scan Novus™ computerized occlusal analysis system (version 10.0.40;
Tekscan, Inc., South Boston, MA, USA).
CoF values closer to zero indicate greater bilateral occlusal balance.
Within-group changes (T0 to T1) and between-group differences were assessed and compared between low-angle (GoGn/SN < 26°) and normal-angle (GoGn/SN 26-38°) subgroups.
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Baseline (T0) and day 15 post-injection (T1)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Anterior and Posterior Force Percentage
大体时间：Baseline (T0) and day 15 post-injection (T1)
|
Anterior force percentage is defined as the combined occlusal force distribution of the anterior teeth, and posterior force percentage as the combined force distribution of the posterior teeth.
Both were measured using the T-Scan Novus™ system at baseline (T0) and day 15 post-injection (T1).
Within-group changes and between-group differences in anterior-posterior force distribution were evaluated and compared between low-angle and normal-angle subgroups.
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Baseline (T0) and day 15 post-injection (T1)
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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
- 学习椅：Esra Agaoğlu Mogul、Department of Orthodontics, Faculty of Dentistry, Biruni 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2月9日
初级完成 (实际的)
2026年5月8日
研究完成 (实际的)
2026年5月8日
研究注册日期
首次提交
2026年6月23日
首先提交符合 QC 标准的
2026年6月23日
首次发布 (实际的)
2026年6月29日
研究记录更新
最后更新发布 (实际的)
2026年6月29日
上次提交的符合 QC 标准的更新
2026年6月23日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- BiruniU-2026-09
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be shared due to patient privacy and ethical restrictions.
Data are available from the corresponding author on reasonable request.
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
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.