Analysis of Muscle Activity With Myofunctional Devices, Using Surface Electromyography

NCT03863275 | Unknown

• 1 other identifier: Electromyography
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Class II Malocclusion

Outcome Measures

Primary Outcomes (3)

• resting muscle activity, initial moment

  Initial Moment . Measure with electromyography in microvolts

  15 seconds

• muscle activity in maximum intercuspidation, second moment

  Measure with electromyography in microvolts.the maximum intercupidation is measured with a dynamometer

  10 seconds

• muscle activity with myofunctional apparatus, third moment

  Measure with electromyography in microvolts.

  10 seconds

Study Arms (2)

No intervation

OTHER

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.

Other: Diagnosis and observation

Myofunctional apparatus

EXPERIMENTAL

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.

Device: functional apparatus

Interventions

functional apparatus DEVICE

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

Myofunctional apparatus

Diagnosis and observation OTHER

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. .

No intervation

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Universitaria CIEO: lead

MeSH Terms

Conditions

Overbite

Interventions

Observation

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class II; Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• carolina alvarez, dra

  35195385

  PRINCIPAL INVESTIGATOR

Central Study Contacts

carolina alvarez, dra

CONTACT

+57 3138590995; caroal24@yahoo.com

Maria Claudia Reyes, dra

CONTACT

+57 3102532309; mariaclarey@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: March 5, 2019
• Study Start: February 26, 2019
• Primary Completion: August 26, 2019
• Study Completion: July 26, 2020
• Last Updated: March 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share