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Analysis of Muscle Activity With Myofunctional Devices, Using Surface Electromyography

Primary Purpose

Class II Malocclusion

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
functional apparatus
Diagnosis and observation
Sponsored by
Fundación Universitaria CIEO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Malocclusion

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    No intervation

    Myofunctional apparatus

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    resting muscle activity, initial moment
    Initial Moment . Measure with electromyography in microvolts
    muscle activity in maximum intercuspidation, second moment
    Measure with electromyography in microvolts.the maximum intercupidation is measured with a dynamometer
    muscle activity with myofunctional apparatus, third moment
    Measure with electromyography in microvolts.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 22, 2019
    Last Updated
    March 4, 2019
    Sponsor
    Fundación Universitaria CIEO
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03863275
    Brief Title
    Analysis of Muscle Activity With Myofunctional Devices, Using Surface Electromyography
    Official Title
    Analysis of Muscle Activity With Myofunctional Devices, Using Surface Electromyography
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 26, 2019 (Anticipated)
    Primary Completion Date
    August 26, 2019 (Anticipated)
    Study Completion Date
    July 26, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fundación Universitaria CIEO

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Class II Malocclusion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    No intervation
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    Myofunctional apparatus
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    functional apparatus
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Diagnosis and observation
    Intervention Description
    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. .
    Primary Outcome Measure Information:
    Title
    resting muscle activity, initial moment
    Description
    Initial Moment . Measure with electromyography in microvolts
    Time Frame
    15 seconds
    Title
    muscle activity in maximum intercuspidation, second moment
    Description
    Measure with electromyography in microvolts.the maximum intercupidation is measured with a dynamometer
    Time Frame
    10 seconds
    Title
    muscle activity with myofunctional apparatus, third moment
    Description
    Measure with electromyography in microvolts.
    Time Frame
    10 seconds

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    carolina alvarez, dra
    Phone
    +57 3138590995
    Email
    caroal24@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maria Claudia Reyes, dra
    Phone
    +57 3102532309
    Email
    mariaclarey@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    carolina alvarez, dra
    Organizational Affiliation
    35195385
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Analysis of Muscle Activity With Myofunctional Devices, Using Surface Electromyography

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