Viewing Study NCT06485375



Ignite Creation Date: 2024-07-17 @ 11:13 AM
Last Modification Date: 2024-10-26 @ 3:33 PM
Study NCT ID: NCT06485375
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-07-03
First Post: 2024-05-21

Brief Title: Electromiographic Evaluation and Skeletal Parameters of Patients Requiring Orthodontic Treatment
Sponsor: University of Pavia
Organization: University of Pavia

Study Overview

Official Title: Electromiographic Evaluation and Skeletal Parameters of Patients Requiring Orthodontic Treatment a Prospective Cross-sectional Study
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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

1 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 μVμV 100
2 Maximum voluntary teeth clenching patients will be asked to clench their teeth in maximum intercuspation as hard as possible for 5 seconds
3 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 μVμV 100
4 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None