Skeletal MalocclusionNCT06485375
Electromiographic Evaluation and Skeletal Parameters of Patients Requiring Orthodontic Treatment
An observational study of Skeletal Malocclusion, run by University of Pavia at 1 site in Italy.
Trial summary
The relationship between form and function within the craniofacial complex has been investigated by several Authors. However, there is still controversy regarding the different electromyographic activation patterns of the elevator muscles of the jaw. Read more about this study
- Who is it for?
- Ages 6 to 25 years
- Conditions the study is for
- Skeletal Malocclusion
- What is being tested?
- EMG
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jul 2024to 25 Sep 2024
- Phase
- Observational
- 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 6 to 25 years
- All sexes
- Child, Adult
Study population: Patients willing to begin orthopedic/orthodontic treatment
Who may be able to join
- Patients needing an orthopaedic and/or orthodontic treatment
- Deciduous, mixed, or permanent dentition
Who cannot join
- Systemic diseases or congenital anomalies affecting craniofacial growth or development
- Signs or symptoms of temporomandibular disorder (TMD)
- Dental Pain
- Past maxillofacial surgery
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: Electromiographic Evaluation and Skeletal Parameters of Patients Requiring Orthodontic Treatment: a Prospective Cross-sectional Study
The relationship between form and function within the craniofacial complex has been investigated by several Authors. However, there is still controversy regarding the different electromyographic activation patterns of the elevator muscles of the jaw. One particularly contentious area of enquiry is whether it is facial morphology that determines the strength of muscle activation, or whether a strong musculature can influence skeletal growth processes.
In light of the aforementioned considerations, the objective of the current clinical observational study was to investigate the potential correlation between the electromyographic activity of selected masticatory muscles (masseter, anterior temporalis and suprahyoid) and the craniofacial morphology of subjects under examination, with a particular focus on elucidating the mechanical advantage derived from different sagittal relationships between the maxillae. The electromyographic evaluation is carried out before the beginning of the orthodontic treatment (T0).
Read the detailed description
The relationship between form and function within the craniofacial complex has been investigated by several Authors. However, there is still controversy regarding the different electromyographic activation patterns of the elevator muscles of the jaw. One particularly contentious area of enquiry is whether it is facial morphology that determines the strength of muscle activation, or whether a strong musculature can influence skeletal growth processes.
In light of the aforementioned considerations, the objective of the current clinical observational study was to investigate the potential correlation between the electromyographic activity of selected masticatory muscles (masseter, anterior temporalis and suprahyoid) and the craniofacial morphology of subjects under examination, with a particular focus on elucidating the mechanical advantage derived from different sagittal relationships between the maxillae. The electromyographic evaluation is carried out before the beginning of the orthodontic treatment (T0).
Muscle activity is commonly recorded by means of surface electromyography (sEMG). However, sEMG data can be affected by various artifacts, resulting in questionable interpretation of the results. A standardisation procedure allows to reduce variability of the assessment of masticatory muscle activity during static and dynamic tasks.
Doing so the position of the electrodes results as follows:
- Masseters electrodes will be fixed parallel to the exocanthion-gonion line and with the upper pole of the electrode under the tragus-labial commissural line.
- Temporalis electrodes will be positioned along the anterior margin of the muscle (corresponding to the frontoparietal suture).
- Suprahyoid muscles electrodes will be placed in the submental area nearly 1 cm posterior to the mental symphysis, paramedian to the midline and lightly diverging.
A reference electrode will be applied on the forehead of the patient. The sEMG analysis will be composed of four parts:
- Masticatory muscle standardisation procedures (repeated thrice): two 10 mm thick cotton rolls will be positioned on the mandibular posterior teeth of each participant, and a 5 second maximum voluntary contraction will be recorded to standardize anterior temporalis and superficial masseters sEMG signals. The mean sEMG potential obtained in the first acquisition was set at 100%, and all further ssEMG potentials will be expressed as a percentage of this value (μV/μV × 100).
- Maximum voluntary teeth clenching: patients will be asked to clench their teeth in maximum intercuspation as hard as possible for 5 seconds.
- Submental muscle standardisation procedures: participants will be asked to push their tongue against the palate (without teeth clenching), and a 5 seconds sEMG suprahyoid muscles activity will be recorded. All further sEMG potentials will be expressed as a percentage of this value (μV/μV × 100).
- Saliva swallowing: participants will be asked to keep their mouth open to accumulate saliva and, when needed, to swallow "freely" (as usual) and a 5 seconds sEMG activity will be recorded.
- Conditions
- Skeletal Malocclusion
- Being tested
- EMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMGDiagnostic test
Disposable bipolar surface electrodes will be used. The patient's skin will be clean with cotton gauze soaked in alcohol before electrodes placement to reduce skin impedance. The operator will palpate the muscle belly while the patient clenches his teeth and will position surface electrodes in parallel to the muscular fibres. Doing so the position of the electrodes results as follows: Masseters electrodes will be fixed parallel to the exocanthion-gonion line and with the upper pole of the electrode under the tragus-labial commissural line. Temporalis electrodes will be positioned along the anterior margin of the muscle (corresponding to the frontoparietal suture). Suprahyoid muscles electrodes will be placed in the submental area nearly 1 cm posterior to the mental symphysis, paramedian to the midline and lightly diverging. A reference electrode will be applied to the forehead of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients requiring orthopedic/orthodontic Receives: Diagnostic Test: EMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Overlapping Coefficient - POC %
It indicates in % the ratio between the activation of the left muscle compared to the right one and its value is between 0 and 100%. A POC of 100% identifies two muscles that activate symmetrically. A lower value shows a greater asymmetry of muscles activation. 95% of subjects without muscular imbalances of dental origin exhibits POC values between 80 and 90%. The POC detected are: Temporalis Anterioris, Masseter Muscle and mean.
Measured: Baseline (T0)
Asymmetry index - ASIM %
It compares the influence of dental contacts on the total activity of the right MM and TA with respect to the left MM and TA. Its value varies between -100% and +100%. A negative value indicates a greater differential activity of the left muscles; conversely, a positive value indicates a greater differential activity of the right muscles. 95% of subjects without muscular imbalances of dental origin exhibits values of asymmetry between ± 10% .
Measured: Baseline (T0)
Activation Index - ATTIV %
3.It compares the influence of dental contacts on the TA activity in relation to MM activity. A negative value implies greater differential recruitment of TA, while a positive value implies greater differential recruitment of the MM. 95% of subjects without muscular imbalances of dental origin exhibits activation values between ± 10%.
Measured: Baseline (T0)
TORQUE %
Torque measures the differential activity of the right TA and left MM in relation to the antagonist torque. A prevalence of the right TA and left MM muscles, or right MM and left TA, may result in twisting forces on the jaw resulting in laterodeviation. This index ranges between -100% and +100%. -100% indicates the total prevalence of left TA and right MM, + 100% indicates the total prevalence of right TA and left MM. 95% of subjects without muscular imbalances of dental origin exhibits torque values between ±10%.
Measured: Baseline (T0)
IMPACT %
It quantifies the total muscular activity performed during MVC relative to the standardization clenching on cotton rolls.
Measured: Baseline (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start3 Jul 2024 (estimated)
- Primary completion15 Sep 2024 (estimated)
- Study completion25 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, MSc, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485375
- Sponsor's protocol ID
- 2024-EMGSKELETAL
- Status last verified
- Jun 2024
- First submitted
- 21 May 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromiographic Evaluation and Skeletal Parameters of Patients Requiring Orthodontic Treatment: a Prospective Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06485375
- Acronym / sponsor ID
- 2024-EMGSKELETAL
- Conditions
- Skeletal Malocclusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 3 Jul 2024 (estimated)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 25 Sep 2024 (estimated)
- First posted
- 3 Jul 2024 (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.
The relationship between form and function within the craniofacial complex has been investigated by several Authors. However, there is still controversy regarding the different electromyographic activation patterns of the elevator muscles of the jaw. One particularly contentious area of enquiry is whether it is facial morphology that determines the strength of muscle activation, or whether a strong musculature can influence skeletal growth processes.
In light of the aforementioned considerations, the objective of the current clinical observational study was to investigate the potential correlation between the electromyographic activity of selected masticatory muscles (masseter, anterior temporalis and suprahyoid) and the craniofacial morphology of subjects under examination, with a particular focus on elucidating the mechanical advantage derived from different sagittal relationships between the maxillae. The electromyographic evaluation is carried out before the beginning of the orthodontic treatment (T0).
Detailed description
The relationship between form and function within the craniofacial complex has been investigated by several Authors. However, there is still controversy regarding the different electromyographic activation patterns of the elevator muscles of the jaw. One particularly contentious area of enquiry is whether it is facial morphology that determines the strength of muscle activation, or whether a strong musculature can influence skeletal growth processes.
In light of the aforementioned considerations, the objective of the current clinical observational study was to investigate the potential correlation between the electromyographic activity of selected masticatory muscles (masseter, anterior temporalis and suprahyoid) and the craniofacial morphology of subjects under examination, with a particular focus on elucidating the mechanical advantage derived from different sagittal relationships between the maxillae. The electromyographic evaluation is carried out before the beginning of the orthodontic treatment (T0).
Muscle activity is commonly recorded by means of surface electromyography (sEMG). However, sEMG data can be affected by various artifacts, resulting in questionable interpretation of the results. A standardisation procedure allows to reduce variability of the assessment of masticatory muscle activity during static and dynamic tasks.
Doing so the position of the electrodes results as follows:
- Masseters electrodes will be fixed parallel to the exocanthion-gonion line and with the upper pole of the electrode under the tragus-labial commissural line.
- Temporalis electrodes will be positioned along the anterior margin of the muscle (corresponding to the frontoparietal suture).
- Suprahyoid muscles electrodes will be placed in the submental area nearly 1 cm posterior to the mental symphysis, paramedian to the midline and lightly diverging.
A reference electrode will be applied on the forehead of the patient. The sEMG analysis will be composed of four parts:
- Masticatory muscle standardisation procedures (repeated thrice): two 10 mm thick cotton rolls will be positioned on the mandibular posterior teeth of each participant, and a 5 second maximum voluntary contraction will be recorded to standardize anterior temporalis and superficial masseters sEMG signals. The mean sEMG potential obtained in the first acquisition was set at 100%, and all further ssEMG potentials will be expressed as a percentage of this value (μV/μV × 100).
- Maximum voluntary teeth clenching: patients will be asked to clench their teeth in maximum intercuspation as hard as possible for 5 seconds.
- Submental muscle standardisation procedures: participants will be asked to push their tongue against the palate (without teeth clenching), and a 5 seconds sEMG suprahyoid muscles activity will be recorded. All further sEMG potentials will be expressed as a percentage of this value (μV/μV × 100).
- Saliva swallowing: participants will be asked to keep their mouth open to accumulate saliva and, when needed, to swallow "freely" (as usual) and a 5 seconds sEMG activity will be recorded.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: EMGPatients requiring orthopedic/orthodontic |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients willing to begin orthopedic/orthodontic treatment
Key inclusion criteria (2 listed)
- Patients needing an orthopaedic and/or orthodontic treatment
- Deciduous, mixed, or permanent dentition
Key exclusion criteria (4 listed)
- Systemic diseases or congenital anomalies affecting craniofacial growth or development
- Signs or symptoms of temporomandibular disorder (TMD)
- Dental Pain
- Past maxillofacial surgery
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 |
|---|---|---|
| EMGDisposable bipolar surface electrodes will be used. The patient's skin will be clean with cotton gauze soaked in alcohol before electrodes placement to reduce skin impedance. The operator will palpate the muscle belly while the patient clenches his teeth and will position surface electrodes in parallel to the muscular fibres. Doing so the position of the electrodes results as follows: Masseters electrodes will be fixed parallel to the exocanthion-gonion line and with the upper pole of the electrode under the tragus-labial commissural line. Temporalis electrodes will be positioned along the anterior margin of the muscle (corresponding to the frontoparietal suture). Suprahyoid muscles electrodes will be placed in the submental area nearly 1 cm posterior to the mental symphysis, paramedian to the midline and lightly diverging. A reference electrode will be applied to the forehead of the patient. | Diagnostic test | Patients |
Primary outcome
Percentage Overlapping Coefficient - POC %
Time frame: Baseline (T0)
It indicates in % the ratio between the activation of the left muscle compared to the right one and its value is between 0 and 100%. A POC of 100% identifies two muscles that activate symmetrically. A lower value shows a greater asymmetry of muscles activation. 95% of subjects without muscular imbalances of dental origin exhibits POC values between 80 and 90%. The POC detected are: Temporalis Anterioris, Masseter Muscle and mean.
Asymmetry index - ASIM %
Time frame: Baseline (T0)
It compares the influence of dental contacts on the total activity of the right MM and TA with respect to the left MM and TA. Its value varies between -100% and +100%. A negative value indicates a greater differential activity of the left muscles; conversely, a positive value indicates a greater differential activity of the right muscles. 95% of subjects without muscular imbalances of dental origin exhibits values of asymmetry between ± 10% .
Activation Index - ATTIV %
Time frame: Baseline (T0)
3.It compares the influence of dental contacts on the TA activity in relation to MM activity. A negative value implies greater differential recruitment of TA, while a positive value implies greater differential recruitment of the MM. 95% of subjects without muscular imbalances of dental origin exhibits activation values between ± 10%.
TORQUE %
Time frame: Baseline (T0)
Torque measures the differential activity of the right TA and left MM in relation to the antagonist torque. A prevalence of the right TA and left MM muscles, or right MM and left TA, may result in twisting forces on the jaw resulting in laterodeviation. This index ranges between -100% and +100%. -100% indicates the total prevalence of left TA and right MM, + 100% indicates the total prevalence of right TA and left MM. 95% of subjects without muscular imbalances of dental origin exhibits torque values between ±10%.
IMPACT %
Time frame: Baseline (T0)
It quantifies the total muscular activity performed during MVC relative to the standardization clenching on cotton rolls.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the Principal Investigator.
Related trials for Skeletal Malocclusion
Active, not recruitingObservational study
Customized CBCT-Based Assessment of Transverse Discrepancies
Transverse Skeletal Discrepancy
Recruiting
Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
Class II Malocclusion
Recruiting
Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates
Malocclusion, Angle Class II
Not yet recruiting
Clinical and Radiographic Evaluation of Low Sagittal Medial Ramus Osteotomy for Treatment of Skeletal Class II and Class III Malocclusion
Skeletal Class II Malocclusion, Skeletal Class III Malocclusion
Active, not recruiting
Modified Versus Clear Twin Block for Skeletal Class II Malocclusion
Skeletal Class II Malocclusion
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.
Andrea Scribante, DDS, PhD, MSc principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skeletal Malocclusion, run by University of Pavia at 1 site in Italy.
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 2 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Andrea Scribante, DDS, PhD, MSc (+39 0382516223, andrea.scribante@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Overlapping Coefficient - POC % (time frame: Baseline (T0)). The study lists 5 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 3 Jul 2024.