Maxillar HypoplasiaNCT05820438
Evaluation of Masticatory Muscle Activity in Pediatric Patients Undergoing Rapid Maxillary Expansion
A study testing Electromyography in people with Maxillar Hypoplasia, run by University of Pavia at 1 site in Italy.
Trial summary
Transverse maxillary constriction is a malocclusion that subsists when the distance between the upper first molars palatal cuspids is lower than the distance between the lower first molars vestibular center fossae. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Maxillar Hypoplasia
- What is being tested?
- Electromyography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- 16 Mar 2023to 30 Mar 2025
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Transverse maxillary constriction
- Patients needing maxillary expansion with Rapid Maxillary Expander (RME)
Who cannot join
- Systemic diseases or congenital anomalies affecting craniofacial growth or development.
- Signs or symptoms of temporomandibular disorder (TMD).
- Dental pain.
- Previous orthopedic/orthodontic treatment/s.
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: Evaluation of Masticatory Muscle Activity in Pediatric Patients Undergoing Rapid Maxillary Expansion: a Prospective Study.
Transverse maxillary constriction is a malocclusion that subsists when the distance between the upper first molars palatal cuspids is lower than the distance between the lower first molars vestibular center fossae. Consequently it can be clinically expressed with a narrow and high palatal vault, a unilateral or bilateral crossbite, dental crowding, and/or reduced volume of the nasal cavities.
It is one of the most common malocclusions in children, with a prevalence of 8 to 22% among orthodontic patients in primary and mixed dentition and 5 to 15% among the general population. The hypothesis of this study is that transverse maxillary constriction correction by Rapid Maxillary Expansor achieves improved muscles activation potential in treated patients and improved symmetry in patient with unilateral crossbite. The aim of this study is to evaluate electromyographic activity of the masseter, anterior temporalis and suprahyoid muscles in clentching, chewing and swallowing in patients undergoing expansion therapy of the maxillary with rapid palatal expander. The electromyographic evaluation is carried out before the treatment (T0), at the end of the expansion (T1) and after 6 months from T1 (T2).
Read the detailed description
Transverse maxillary constriction subsists when the distance between upper first molars palatal cuspids is lower than the distance between lower first molars vestibular central fossae. It can be clinically expressed with a narrow and high palatal vault, a unilateral or bilateral crossbite, dental crowding and/or reduced volume of the nasal cavities. It is one of the most common malocclusions in children, with a prevalence of 8 to 22% among orthodontic patients in primary and mixed dentition and 5 to 15% among general population. The hypothesis of this study is that transverse maxillary constriction correction by Rapid Maxillary Expander (RME) affects masticatory muscles activation potential and improves activation symmetry in patient with unilateral crossbite. The aim of this study is to evaluate electromyographic activity of masseters, anterior temporalis and suprahyoid muscles in clenching, chewing and swallowing in patients undergoing maxillary expansion with RME. The electromyographic evaluation is carried out before treatment (T0), at the end of the expansion (T1) and 6 months later (T2). Detailed Description: Transverse maxillary constriction subsists when the distance between upper first molars palatal cuspids is lower than the distance between lower first molars vestibular central fossae. It can be clinically expressed with a narrow and high palatal vault, a unilateral or bilateral crossbite, dental crowding and/or reduced volume of the nasal cavities. It is one of the most common malocclusions in children, with a prevalence of 8 to 22% among orthodontic patients in primary and mixed dentition and 5 to 15% among general population. One of the most frequent expression of transverse maxillary constriction is unilateral crossbite, that consists in an inverted bucco-lingual relationship between one or more posterior teeth (canine to molars) with their antagonists; it can be present both in deciduous and permanent dentition. There is evidence that an altered relationship between upper and lower teeth is associated with asymmetric masticatory function that has been related to asymmetric contraction of masticatory muscles, decreased thickness of the cross-sided masseter muscle and altered masticatory pattern. This condition could lead to an asymmetric development of the mandibular bone during growth. Many authors conclude that early treatment of transverse maxillary constriction with RME would be recommended to reduce the risk of development of skeletal asymmetries and temporomandibular disorders (TMD). 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.
- Page 2 of 6 [DRAFT] -
The hypotheses of this study are:
Patients with transverse maxillary constriction improve muscles activation potential after rapid maxillary expansion; correction of unilateral posterior crossbite by rapid maxillary expansion improves muscles activation potential symmetry.
The main objectives of this study are:
- to evaluate the activity of superficial masseters, anterior temporalis and suprahyoid muscles in patients with traverse maxillary constriction, using surface electromyography with a standardized protocol. The test consists of detecting muscles activity in maximum clenching (on cottons and on teeth), during swallowing and chewing;
- to evaluate whether the presence of unilateral posterior crossbite is associated with asymmetrical activation of superficial masseters, anterior temporalis and suprahyoid muscles;
- to compare intra-patient results before and after traverse maxillary constriction correction. The electromyograph that will be used is Easy-MYo EMG Tracer of 3 Technology Srl; Udine, Italy. It records muscular activity of superficial masseters, anterior temporalis and suprahyoid muscles. Disposable bipolar surface electrodes (21 × 41 mm, 20 mm inter-electrode distance; F3010; Fiab) 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 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 on the forehead of the patient.
The sEMG analysis will be composed of four parts:
Masticatory muscle standardisation procedures (repeated thrice):
two 10mm 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.
Three EMG sessions will be recorded:
- before starting treatment with Rapid Maxillary Expander (RME) (T0);
- at the end of RME activation (T1), established by the clinician, generally looking for hypercorrection, that is contact between upper molar palatal cuspid and lower molar buccal cuspid.
- after 6 months from T1 (T2).
- Conditions
- Maxillar Hypoplasia
- Being tested
- Electromyography
- Medical subject headings
- Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectromyographyDevice
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 requiring orthopedic treatment with Rapid Maxillary Expander | Experimental | Patients will be treated with Rapid Maxillary Expander with two bands on the upper first permanent molars or upper second primary molars (depending on the eruptive stage of the patient). The screw will be activated according to clinitian's indication until a transverse overcorrection of 2 mm is achieved in the first permanent molars. When the active disjunction phase is completed, the screw will be blocked out with a metal legature and the patient will wear the cemented RME for retentions at least for six months. Receives: Device: Electromyography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percentage Overlapping Coefficient - POC %
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. There were 95% of subjects without muscular imbalances of dental origin who had POC values between 80 and 90% (Ferrario et al, 2000). The POC detected are: TA, MM and mean.
Measured: Baseline (T0), end of activations - approximately 14-30 days - (T1), after 6 months from T1 (T2)
Change in 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. There was a total of 95% of subjects without muscular imbalances of dental origin having values of asymmetry between ± 10% (Ferrario et al, 2000);
Measured: Baseline (T0), end of activations - approximately 14-30 days - (T1), after 6 months from T1 (T2)
Change in Activation Index - ATTIV %
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. There was a total of 95% of subjects without muscular imbalances of dental origin having activation values between ± 10% (Ferrario et al, 2000);
Measured: Baseline (T0), end of activations- approximately 14-30 days - (T1), after 6 months from T1 (T2)
Change in 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 latero-deviation. 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. There was a total of 95% of subjects without muscular imbalances of dental origin having torque values between ±10% (Ferrario et al, 2000).
Measured: Baseline (T0), end of activations- approximately 14-30 days - (T1), after 6 months from T1 (T2)
Change in IMPACT %
It quantifies the total muscular activity performed during MVC relative to the standardization clenching on cotton rolls.
Measured: Baseline (T0), end of activations - approximately 14-30 days - (T1), after 6 months from T1 (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start16 Mar 2023
- Primary completion20 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillar HypoplasiaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
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, Mac, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820438
- Sponsor's protocol ID
- 2023-EMGRME
- Status last verified
- Sep 2025
- First submitted
- 14 Mar 2023
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are available upon motivated request to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Masticatory Muscle Activity in Pediatric Patients Undergoing Rapid Maxillary Expansion: a Prospective Study.
- ClinicalTrials.gov ID
- NCT05820438
- Acronym / sponsor ID
- 2023-EMGRME
- Conditions
- Maxillar Hypoplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 19 Apr 2023 (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.
Transverse maxillary constriction is a malocclusion that subsists when the distance between the upper first molars palatal cuspids is lower than the distance between the lower first molars vestibular center fossae. Consequently it can be clinically expressed with a narrow and high palatal vault, a unilateral or bilateral crossbite, dental crowding, and/or reduced volume of the nasal cavities.
It is one of the most common malocclusions in children, with a prevalence of 8 to 22% among orthodontic patients in primary and mixed dentition and 5 to 15% among the general population. The hypothesis of this study is that transverse maxillary constriction correction by Rapid Maxillary Expansor achieves improved muscles activation potential in treated patients and improved symmetry in patient with unilateral crossbite. The aim of this study is to evaluate electromyographic activity of the masseter, anterior temporalis and suprahyoid muscles in clentching, chewing and swallowing in patients undergoing expansion therapy of the maxillary with rapid palatal expander. The electromyographic evaluation is carried out before the treatment (T0), at the end of the expansion (T1) and after 6 months from T1 (T2).
Detailed description
Transverse maxillary constriction subsists when the distance between upper first molars palatal cuspids is lower than the distance between lower first molars vestibular central fossae. It can be clinically expressed with a narrow and high palatal vault, a unilateral or bilateral crossbite, dental crowding and/or reduced volume of the nasal cavities. It is one of the most common malocclusions in children, with a prevalence of 8 to 22% among orthodontic patients in primary and mixed dentition and 5 to 15% among general population. The hypothesis of this study is that transverse maxillary constriction correction by Rapid Maxillary Expander (RME) affects masticatory muscles activation potential and improves activation symmetry in patient with unilateral crossbite. The aim of this study is to evaluate electromyographic activity of masseters, anterior temporalis and suprahyoid muscles in clenching, chewing and swallowing in patients undergoing maxillary expansion with RME. The electromyographic evaluation is carried out before treatment (T0), at the end of the expansion (T1) and 6 months later (T2). Detailed Description: Transverse maxillary constriction subsists when the distance between upper first molars palatal cuspids is lower than the distance between lower first molars vestibular central fossae. It can be clinically expressed with a narrow and high palatal vault, a unilateral or bilateral crossbite, dental crowding and/or reduced volume of the nasal cavities. It is one of the most common malocclusions in children, with a prevalence of 8 to 22% among orthodontic patients in primary and mixed dentition and 5 to 15% among general population. One of the most frequent expression of transverse maxillary constriction is unilateral crossbite, that consists in an inverted bucco-lingual relationship between one or more posterior teeth (canine to molars) with their antagonists; it can be present both in deciduous and permanent dentition. There is evidence that an altered relationship between upper and lower teeth is associated with asymmetric masticatory function that has been related to asymmetric contraction of masticatory muscles, decreased thickness of the cross-sided masseter muscle and altered masticatory pattern. This condition could lead to an asymmetric development of the mandibular bone during growth. Many authors conclude that early treatment of transverse maxillary constriction with RME would be recommended to reduce the risk of development of skeletal asymmetries and temporomandibular disorders (TMD). 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.
- Page 2 of 6 [DRAFT] -
The hypotheses of this study are:
Patients with transverse maxillary constriction improve muscles activation potential after rapid maxillary expansion; correction of unilateral posterior crossbite by rapid maxillary expansion improves muscles activation potential symmetry.
The main objectives of this study are:
- to evaluate the activity of superficial masseters, anterior temporalis and suprahyoid muscles in patients with traverse maxillary constriction, using surface electromyography with a standardized protocol. The test consists of detecting muscles activity in maximum clenching (on cottons and on teeth), during swallowing and chewing;
- to evaluate whether the presence of unilateral posterior crossbite is associated with asymmetrical activation of superficial masseters, anterior temporalis and suprahyoid muscles;
- to compare intra-patient results before and after traverse maxillary constriction correction. The electromyograph that will be used is Easy-MYo EMG Tracer of 3 Technology Srl; Udine, Italy. It records muscular activity of superficial masseters, anterior temporalis and suprahyoid muscles. Disposable bipolar surface electrodes (21 × 41 mm, 20 mm inter-electrode distance; F3010; Fiab) 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 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 on the forehead of the patient.
The sEMG analysis will be composed of four parts:
Masticatory muscle standardisation procedures (repeated thrice):
two 10mm 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.
Three EMG sessions will be recorded:
- before starting treatment with Rapid Maxillary Expander (RME) (T0);
- at the end of RME activation (T1), established by the clinician, generally looking for hypercorrection, that is contact between upper molar palatal cuspid and lower molar buccal cuspid.
- after 6 months from T1 (T2).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring orthopedic treatment with Rapid Maxillary Expander | Experimental | Device: ElectromyographyPatients will be treated with Rapid Maxillary Expander with two bands on the upper first permanent molars or upper second primary molars (depending on the eruptive stage of the patient). The screw will be activated according to clinitian's indication until a transverse overcorrection of 2 mm is achieved in the first permanent molars. When the active disjunction phase is completed, the screw will be blocked out with a metal legature and the patient will wear the cemented RME for retentions at least for six months. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Transverse maxillary constriction
- Patients needing maxillary expansion with Rapid Maxillary Expander (RME)
Key exclusion criteria (4 listed)
- Systemic diseases or congenital anomalies affecting craniofacial growth or development.
- Signs or symptoms of temporomandibular disorder (TMD).
- Dental pain.
- Previous orthopedic/orthodontic treatment/s.
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 |
|---|---|---|
| ElectromyographyDisposable 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. | Device | Patients requiring orthopedic treatment with Rapid Maxillary Expander |
Primary outcome
Change in Percentage Overlapping Coefficient - POC %
Time frame: Baseline (T0), end of activations - approximately 14-30 days - (T1), after 6 months from T1 (T2)
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. There were 95% of subjects without muscular imbalances of dental origin who had POC values between 80 and 90% (Ferrario et al, 2000). The POC detected are: TA, MM and mean.
Change in Asymmetry index - ASIM %
Time frame: Baseline (T0), end of activations - approximately 14-30 days - (T1), after 6 months from T1 (T2)
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. There was a total of 95% of subjects without muscular imbalances of dental origin having values of asymmetry between ± 10% (Ferrario et al, 2000);
Change in Activation Index - ATTIV %
Time frame: Baseline (T0), end of activations- approximately 14-30 days - (T1), after 6 months from T1 (T2)
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. There was a total of 95% of subjects without muscular imbalances of dental origin having activation values between ± 10% (Ferrario et al, 2000);
Change in TORQUE %
Time frame: Baseline (T0), end of activations- approximately 14-30 days - (T1), after 6 months from T1 (T2)
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 latero-deviation. 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. There was a total of 95% of subjects without muscular imbalances of dental origin having torque values between ±10% (Ferrario et al, 2000).
Change in IMPACT %
Time frame: Baseline (T0), end of activations - approximately 14-30 days - (T1), after 6 months from T1 (T2)
It quantifies the total muscular activity performed during MVC relative to the standardization clenching on cotton rolls.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No. Data are available upon motivated request to the Principal Investigator.
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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.
Andrea Scribante, DDS, PhD, Mac 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?
A study testing Electromyography in people with Maxillar Hypoplasia, 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: finished, as of the sponsor's last update on 25 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percentage Overlapping Coefficient - POC % (time frame: Baseline (T0), end of activations - approximately 14-30 days - (T1), after 6 months from T1 (T2)). 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 25 Sep 2025.