Analysis of Muscle Activity With Myofunctional Devices, Using Surface Electromyography
Importance and justification The importance of carrying out this study is to verify the electrical activity generated by the masticatory muscles to be able to have clarity of their performance in the development of orthopedic treatment, thus complementing the diagnosis to achieve a more successful treatment with myofunctional device SN1 in Class II malocclusions.
In addition, with the results of this study, treatment prediction criteria are provided to the clinician, depending on the thickness of the muscle, more specific equipment will be chosen to solve the malocclusion and prognosis when using the SN1 myofunctional device in class II malocclusions.
Additionally, it has academic utility, since there is little scientific evidence about myofunctional SN1 device and its impact on masticatory muscles, thus opening the door to a line of research where this study can be used as a basis for future orthopedic clinical research. in UNICIEO.
Added to this and according to the results, the knowledge about the SN1 will be updated, thus providing evidence for the teaching of orthopedics for the students; and also a measurement protocol with electromyography for children will be provided Overall objective To evaluate the electrical activity of the masseter and temporal muscles in patients from 7 to 12 years of age, with skeletal class II who are under treatment with myofunctional apparatus (Sn1), in the UNICIEO orthopedics clinic by means of kinesiological electromyography compare with a control group without use of the device Specific objectives
- Determine the activity of the masseter and temporal muscles of patients at rest (without functional orthopedic apparatus) in the two study groups.
- To determine the activity of the masseter and temporal muscles of the patients after the use of functional orthopedic equipment (Sn1), after six months of treatment and in the control group without treatment.
研究概览
详细说明
Study design Prospective nonrandomized controlled clinical trial, 1: 1 allocation Participants Study group. Boys and girls between 7 and 12 years skeletal class II, for the study group the individuals will be selected from the UNICIEO postgraduate clinic of orthopedic clinic orthodontics after conducting a full clinical case study exposed to a board of specialist teachers in orthodontics, where by means of several diagnostic methods a skeletal class II is confirmed that involves a treatment with myofunctional apparatus SN1; patients presenting syndromes that generate craniofacial alterations, patients with previous orthopedic treatment, patients with signs of condyle lesions, patients with Pierre Robin syndrome or any form of slit will be excluded.
Control group. Children aged between 7 and 12 years diagnosed with class II dental classification, who attend the Leonardo Da Vinci School after carrying out an intraoral and extraoral photography study and diagnostic impressions with study models accepting participation in the study, children over the age of 12 will have to sign an agreement, patients who present syndromes that generate craniofacial alterations, patients with previous orthopedic treatment, patients with Pierre Robin syndrome or any form of slit will be excluded.
Interventions or independent variables
- Use of Sn1 equipment in the study group: the study participants are placed, which correspond to the study group, the Sn1 apparatus of which is composed of dorsal arches with an hourly intensity of 12 hours a day, where a control will be carried out monthly.
- Six months of observation in the control group: patients in the control group will be given informed consent, children over the age of 12 will have to sign an informed consent, then a photographic study of intraoral and extraoral photos will be made, impressions to obtain models and have an observation of the molar classification, and verify if it has the inclusion criteria of the study, once that participation is confirmed, the muscular activity of the masticatory muscles will be observed, in two times, at the beginning and at six months after.
Results or dependent variables.
Masseter and temporal muscle activity measured with EMG (microvolts) in the following moments:
Moment of measurement: the electrical activity will be taken at 2 moments of the study.
T0: Initial Moment
- Rest: A record of electromyography will be taken where the patient has a natural position of the head and is in complete rest, resting time (60 seconds)
- Maximum intercuspidation: The patient will be instructed to perform a force that will be measured with a dynamometer where it generates a dental tightening, to verify the electrical activity that is generated in that maximum contraction of masseter muscles captured by the electromyograph.
- Use of the device: a record of the muscular activity will be made at the moment the patient puts on the Sn1 device.
T1: six months of use of functional equipment (Sn1)
- Rest: A record of electromyography will be taken where the patient has a natural position of the head and is in complete rest, resting time (60 seconds)
- Maximum intercuspidation: The patient will be instructed to perform a force that will be measured with a dynamometer where it generates a dental tightening, to verify the electrical activity that is generated in that maximum contraction of masseter muscles captured by the electromyograph.
- Use of equipment (study group) will be a record of muscle activity at the time the patient puts on the Sn1 device
Sample size To date, no similar studies have been located, therefore a pilot test will be carried out with 10 patients from each group and with the result the sample size of the study will be calculated.
Statistical Methods The data will initially be tested using the Shapiro-Wilk test. Maximum changes in molar bite force during treatment or observation (T0 - T1) will be evaluated, and t-paired tests will be used to evaluate the statistical significance within each group. A comparison of the changes between the treatment and control groups will also be carried out using t-unpaired tests. Parametric analyzes will be used: Anova, Multivariate analysis of variance (Manova), T2 Hotelling test. All correlations were considered significant with p <0.05.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:carolina alvarez, dra
- 电话号码:+57 3138590995
- 邮箱:caroal24@yahoo.com
研究联系人备份
- 姓名:Maria Claudia Reyes, dra
- 电话号码:+57 3102532309
- 邮箱:mariaclarey@hotmail.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Boys and girls from 7 to 12 years old with class II skeletal classification attending a consultation in the dental clinic of the UNICIEO foundation, to be fitted with myofunctional apparatus type Sn1
Exclusion Criteria:
- Patients who have had previous orthopedic treatment
- Patients with signs of condyle injuries
- Patients of Pierre Robin or any form of cleft
- Patients with syndromes that associate craniofacial anomalies and muscle alterations.
学习计划
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 |
---|---|
其他:No intervation
Children between the ages of 7 and 12 diagnosed with class II dental classification, who attend the Leonardo Da Vinci School after carrying out an intraoral and extraoral photography study and diagnostic impressions with study models accepting participation in the study, Children over the age of 12 who have an agreement according to the results of medical care.
Patients with Pierre Robin syndrome or any form of cleft.
|
Six months of observation in the control group: patients group the efforts are controlled.
to obtain models and have an observation of the molar classification, and to verify if the terms of the inclusion in the study are taken into account, once it is confirmed that the activity is observed in the muscular activity of the chewing muscles, in two stages , at the beginning of the session and six months later. .
|
实验性的:Myofunctional apparatus
Boys and girls between 7 and 12 years skeletal class II, for the study group the individuals will be selected from the UNICIEO postgraduate clinic of orthopedic clinic orthodontics after conducting a full clinical case study exposed to a board of specialist teachers in orthodontics, where by means of several diagnostic methods a skeletal class II is confirmed that involves a treatment with myofunctional apparatus SN1; patients presenting syndromes that generate craniofacial alterations, patients with previous orthopedic treatment, patients with signs of condyle lesions, patients with Pierre Robin syndrome or any form of slit will be excluded.
|
The EMG activity will be recorded during different shots: T0.
The activity of the muscles of the mastication in the position of clinical rest for a minute, in maximum intercuspidation.
(It will be measured with a dynamometer to standardize the force), and with the use of the equipment.
T1 The patient's citation is scheduled six months after the use of myofunctional device Sn1 and the test will be performed again measuring electrical activity of right and left masseter and right and left temporal muscle at clinical rest for one minute, in maximum intercuspation, and with the use of the equipment To avoid the effects of fatigue, a rest period of at least 5 minutes between each of the recordings will be allowed
|
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 |
---|---|---|
resting muscle activity, initial moment
大体时间:15 seconds
|
Initial Moment .
Measure with electromyography in microvolts
|
15 seconds
|
muscle activity in maximum intercuspidation, second moment
大体时间:10 seconds
|
Measure with electromyography in microvolts.the
maximum intercupidation is measured with a dynamometer
|
10 seconds
|
muscle activity with myofunctional apparatus, third moment
大体时间:10 seconds
|
Measure with electromyography in microvolts.
|
10 seconds
|
合作者和调查者
调查人员
- 首席研究员:carolina alvarez, dra、35195385
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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
- Electromyography
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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