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临床试验/NCT05820438
NCT05820438已完成不适用

Evaluation of Masticatory Muscle Activity in Pediatric Patients Undergoing Rapid Maxillary Expansion: a Prospective Study.

University of Pavia2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Change in IMPACT %

研究概览

简要总结

Transverse maxillary constriction is a malocclusion that subsists when the distance between the upper first molars palatal cuspids is lower than the distance between the lower first molars vestibular center fossae. Consequently it can be clinically expressed with a narrow and high palatal vault, a unilateral or bilateral crossbite, dental crowding, and/or reduced volume of the nasal cavities.

It is one of the most common malocclusions in children, with a prevalence of 8 to 22% among orthodontic patients in primary and mixed dentition and 5 to 15% among the general population. The hypothesis of this study is that transverse maxillary constriction correction by Rapid Maxillary Expansor achieves improved muscles activation potential in treated patients and improved symmetry in patient with unilateral crossbite. The aim of this study is to evaluate electromyographic activity of the masseter, anterior temporalis and suprahyoid muscles in clentching, chewing and swallowing in patients undergoing expansion therapy of the maxillary with rapid palatal expander. The electromyographic evaluation is carried out before the treatment (T0), at the end of the expansion (T1) and after 6 months from T1 (T2).

详细描述

Transverse maxillary constriction subsists when the distance between upper first molars palatal cuspids is lower than the distance between lower first molars vestibular central fossae. It can be clinically expressed with a narrow and high palatal vault, a unilateral or bilateral crossbite, dental crowding and/or reduced volume of the nasal cavities. It is one of the most common malocclusions in children, with a prevalence of 8 to 22% among orthodontic patients in primary and mixed dentition and 5 to 15% among general population. The hypothesis of this study is that transverse maxillary constriction correction by Rapid Maxillary Expander (RME) affects masticatory muscles activation potential and improves activation symmetry in patient with unilateral crossbite. The aim of this study is to evaluate electromyographic activity of masseters, anterior temporalis and suprahyoid muscles in clenching, chewing and swallowing in patients undergoing maxillary expansion with RME. The electromyographic evaluation is carried out before treatment (T0), at the end of the expansion (T1) and 6 months later (T2). Detailed Description: Transverse maxillary constriction subsists when the distance between upper first molars palatal cuspids is lower than the distance between lower first molars vestibular central fossae. It can be clinically expressed with a narrow and high palatal vault, a unilateral or bilateral crossbite, dental crowding and/or reduced volume of the nasal cavities. It is one of the most common malocclusions in children, with a prevalence of 8 to 22% among orthodontic patients in primary and mixed dentition and 5 to 15% among general population. One of the most frequent expression of transverse maxillary constriction is unilateral crossbite, that consists in an inverted bucco-lingual relationship between one or more posterior teeth (canine to molars) with their antagonists; it can be present both in deciduous and permanent dentition. There is evidence that an altered relationship between upper and lower teeth is associated with asymmetric masticatory function that has been related to asymmetric contraction of masticatory muscles, decreased thickness of the cross-sided masseter muscle and altered masticatory pattern. This condition could lead to an asymmetric development of the mandibular bone during growth. Many authors conclude that early treatment of transverse maxillary constriction with RME would be recommended to reduce the risk of development of skeletal asymmetries and temporomandibular disorders (TMD). Muscle activity is commonly recorded by means of surface electromyography (sEMG). However sEMG data can be affected by various artifacts, resulting in questionable interpretation of the results. A standardisation procedure allows to reduce variability of the assessment of masticatory muscle activity during static and dynamic tasks.

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The hypotheses of this study are:

Patients with transverse maxillary constriction improve muscles activation potential after rapid maxillary expansion; correction of unilateral posterior crossbite by rapid maxillary expansion improves muscles activation potential symmetry.

The main objectives of this study are:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Transverse maxillary constriction
  • Patients needing maxillary expansion with Rapid Maxillary Expander (RME)

排除标准

  • Systemic diseases or congenital anomalies affecting craniofacial growth or development.
  • Signs or symptoms of temporomandibular disorder (TMD).
  • Dental pain.
  • Previous orthopedic/orthodontic treatment/s.

结局指标

主要结局

Change in IMPACT %

时间窗: Baseline (T0), end of activations - approximately 14-30 days - (T1), after 6 months from T1 (T2)

It quantifies the total muscular activity performed during MVC relative to the standardization clenching on cotton rolls.

Change in Asymmetry index - ASIM %

时间窗: Baseline (T0), end of activations - approximately 14-30 days - (T1), after 6 months from T1 (T2)

It compares the influence of dental contacts on the total activity of the right MM and TA with respect to the left MM and TA. Its value varies between -100% and +100%. A negative value indicates a greater differential activity of the left muscles; conversely, a positive value indicates a greater differential activity of the right muscles. There was a total of 95% of subjects without muscular imbalances of dental origin having values of asymmetry between ± 10% (Ferrario et al, 2000);

Change in TORQUE %

时间窗: Baseline (T0), end of activations- approximately 14-30 days - (T1), after 6 months from T1 (T2)

Torque measures the differential activity of the right TA and left MM in relation to the antagonist torque. A prevalence of the right TA and left MM muscles, or right MM and left TA, may result in twisting forces on the jaw resulting in latero-deviation. This index ranges between -100% and +100%. -100% indicates the total prevalence of left TA and right MM, + 100% indicates the total prevalence of right TA and left MM. There was a total of 95% of subjects without muscular imbalances of dental origin having torque values between ±10% (Ferrario et al, 2000).

Change in Percentage Overlapping Coefficient - POC %

时间窗: Baseline (T0), end of activations - approximately 14-30 days - (T1), after 6 months from T1 (T2)

Indicates in % the ratio between the activation of the left muscle compared to the right one and its value is between 0 and 100%. A POC of 100% identifies two muscles that activate symmetrically. A lower value shows a greater asymmetry of muscles activation. There were 95% of subjects without muscular imbalances of dental origin who had POC values between 80 and 90% (Ferrario et al, 2000). The POC detected are: TA, MM and mean.

Change in Activation Index - ATTIV %

时间窗: Baseline (T0), end of activations- approximately 14-30 days - (T1), after 6 months from T1 (T2)

It compares the influence of dental contacts on the TA activity in relation to MM activity. A negative value implies greater differential recruitment of TA, while a positive value implies greater differential recruitment of the MM. There was a total of 95% of subjects without muscular imbalances of dental origin having activation values between ± 10% (Ferrario et al, 2000);

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Scribante

Associate Professor, Principal Investigator

University of Pavia

研究点 (2)

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