Electromiographic Evaluation and Skeletal Parameters of Patients Requiring Orthodontic Treatment

NCT06485375 | Not Yet Recruiting

• 1 other identifier: 2024-EMGSKELETAL
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Skeletal Malocclusion

Outcome Measures

Primary Outcomes (5)

• 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.

  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% .

  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%.

  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%.

  Baseline (T0)

• IMPACT %

  It quantifies the total muscular activity performed during MVC relative to the standardization clenching on cotton rolls.

  Baseline (T0)

Study Arms (1)

Patients

Patients requiring orthopedic/orthodontic

Diagnostic Test: EMG

Interventions

EMG DIAGNOSTIC_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.

Patients

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients willing to begin orthopedic/orthodontic treatment

You may qualify if:

• Patients needing an orthopaedic and/or orthodontic treatment
• Deciduous, mixed, or permanent dentition

You may not qualify if:

• Systemic diseases or congenital anomalies affecting craniofacial growth or development
• Signs or symptoms of temporomandibular disorder (TMD)
• Dental Pain
• Past maxillofacial surgery

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

Location

Study Officials

• Andrea Scribante, DDS, PhD, MSc

  University of Pavia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Scribante, DDS, PhD, MSc

CONTACT

+39 0382516223; andrea.scribante@unipv.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: July 3, 2024
• Study Start: July 3, 2024
• Primary Completion: September 15, 2024
• Study Completion: September 25, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)