Class II Malocclusion Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | July 26, 2020 |
Est. primary completion date | August 26, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 12 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fundación Universitaria CIEO |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | resting muscle activity, initial moment | Initial Moment . Measure with electromyography in microvolts | 15 seconds | |
Primary | muscle activity in maximum intercuspidation, second moment | Measure with electromyography in microvolts.the maximum intercupidation is measured with a dynamometer | 10 seconds | |
Primary | muscle activity with myofunctional apparatus, third moment | Measure with electromyography in microvolts. | 10 seconds |
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