Class II MalocclusionNCT03863275
Analysis of Muscle Activity With Myofunctional Devices, Using Surface Electromyography
A study testing functional apparatus and Diagnosis and observation in people with Class II Malocclusion, run by Fundación Universitaria CIEO.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Malocclusion
- What is being tested?
- functional apparatus and Diagnosis and observation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 26 Feb 2019to 26 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Class II Malocclusion
- Being tested
- functional apparatus, Diagnosis and observation
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional apparatusDevice
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
Diagnosis and observationOther
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. .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: functional apparatus |
What is being measured
The primary outcome is the main question the study is designed to answer.
resting muscle activity, initial moment
Initial Moment . Measure with electromyography in microvolts
Measured: 15 seconds
muscle activity in maximum intercuspidation, second moment
Measure with electromyography in microvolts.the maximum intercupidation is measured with a dynamometer
Measured: 10 seconds
muscle activity with myofunctional apparatus, third moment
Measure with electromyography in microvolts.
Measured: 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start26 Feb 2019 (estimated)
- Primary completion26 Aug 2019 (estimated)
- Study completion26 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Universitaria CIEO
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Alvarez, Fundación Universitaria CIEO
- Investigators
- carolina alvarez, dra, Principal investigator, 35195385
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863275
- Sponsor's protocol ID
- Electromyography
- Status last verified
- Feb 2019
- First submitted
- 22 Feb 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Muscle Activity With Myofunctional Devices, Using Surface Electromyography
- ClinicalTrials.gov ID
- NCT03863275
- Acronym / sponsor ID
- Electromyography
- Conditions
- Class II Malocclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundación Universitaria CIEOUniversity, hospital or other
- Study start
- 26 Feb 2019 (estimated)
- Primary completion
- 26 Aug 2019 (estimated)
- Study completion
- 26 Jul 2020 (estimated)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervation | Other | Other: Diagnosis and observationChildren 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. |
| Myofunctional apparatus | Experimental | Device: functional apparatusBoys 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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional apparatusThe 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 | Device | Myofunctional apparatus |
| Diagnosis and observationSix 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. . | Other | No intervation |
Primary outcome
resting muscle activity, initial moment
Time frame: 15 seconds
Initial Moment . Measure with electromyography in microvolts
muscle activity in maximum intercuspidation, second moment
Time frame: 10 seconds
Measure with electromyography in microvolts.the maximum intercupidation is measured with a dynamometer
muscle activity with myofunctional apparatus, third moment
Time frame: 10 seconds
Measure with electromyography in microvolts.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
carolina alvarez, dra principal investigator
35195385
Questions about this trial
What is this clinical trial studying?
A study testing functional apparatus and Diagnosis and observation in people with Class II Malocclusion, run by Fundación Universitaria CIEO.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact carolina alvarez, dra (+57 3138590995, caroal24@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resting muscle activity, initial moment (time frame: 15 seconds). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.