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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Italy

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.

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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:

  1. before starting treatment with Rapid Maxillary Expander (RME) (T0);
  2. 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.
  3. after 6 months from T1 (T2).
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 groups in NCT05820438
Study groupRoleWhat they receive
Patients requiring orthopedic treatment with Rapid Maxillary ExpanderExperimentalPatients 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.

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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.

  1. First posted19 Apr 2023
  2. Study start16 Mar 2023
  3. Primary completion20 Mar 2025
  4. Study completion30 Mar 2025

Resources

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)
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.

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.

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