Orthodontic Clear Aligners Vs Conventional Fixed Appliance's Impact on Muscular Activities Among Adults Using SEMG (Surface Electromyography)

An Orthodontic Clear Aligners Vs Conventional Fixed Appliances Impact on Muscular Activities Among Adults: a Surface Electromyography (sEMG) Prospective Comparative Study

This clinical trial goal is to evaluate the difference in masticatory activities in adult patients treated with clear aligners compared to conventional fixed appliances treatment.

The aim of this study is to measure the changes of the activity of the anterior temporalis and masseter muscles in different treatment modality.

The activity of the muscles will be evaluated and measured using the surface electromyography (sEMG) BioRadio device before and after the beginning of each treatment modality.

Study Overview

• Status: Not yet recruiting
• Conditions: Masseter Muscle Activity; Anterior Temporalis Muscle Activity

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Ali M Alshamrani, Bachelor degree in Dentistry.; Phone Number: +966580111225; Email: ali.m.alshamrani2023@student.riyadh.edu.sa

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 12734
    • Riyadh Elm University
    • Contact: Post graduate studies office, Masters degree in orthodontics; Phone Number: +966112100000; Email: postgraduate@riyadh.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be enrolled from Riyadh Elm University, Orthodontic Clinics, along with other private centers, Riyadh, Kingdom of Saudi Arabia.

Description

Inclusion Criteria:

• Adult Participants aged 16 years old and above.
• Healthy growing Participants without any systemic diseases (assessed by taking a brief medical history ).
• Participants with skeletal Class I relationship.
• Participants with any other dental malocclusion referring to the Index of Orthodontic Treatment Need Index of orthodontic treatment needed (IOTN) .
• No active extensive caries and with healthy periodontal tissues.

Exclusion Criteria:

• Participants with any craniofacial anomalies, mental disabilities and/or neuropathic conditions.
• Participants with history of neuromuscular disease and/ or truma.
• Participants with the Presence of skeletal and/or diagnosed muscular asymmetries.
• Participants with History of any previous orthodontic treatment.
• Participants who have any signs of bruxism.
• Participants with history of use of muscle relaxants.
• Participants with true crossbites and/or with signs of Temporomandibular disorders (TMD) or condylar problems.
• Participants with skeletal CL II and/or CL III relationships.
• Participants with Hypodontia and/or with multiple missing posterior teeth (4 teeth and more).
• Participants with maxillary constriction and posterior cross-bite (unilateral or bilateral) with an indication for orthognathic surgery.
• Participants indicated for extraction orthodontic treatment.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Clear aligner therapy group
Conventional fixed therapy group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of muscular activity in clear aligners vs conventional fixed orthodontic therapies at 3 months using the BioRadio sEMG device.	Muscle activity will be recorded using the BioRadio device in four statuses: Rest; Clenching 1: participants will be asked to apply maximum voluntary clenching MVC; Clenching 2: participants will be asked to apply MVC on a standardized cotton roll.; Mastication: participants will be instructed to chew on a standardized sugar free chewing gum.	The muscle activity with the BioRadio device will be recorded as follows: T0: Before start of orthodontic treatment, T1: One month after start of orthodontic treatment,T2: Three months after the start of orthodontic treatment.

Collaborators and Investigators

• Sponsor: Riyadh Elm University

Publications and helpful links

General Publications

• Nota A, Caruso S, Ehsani S, Ferrazzano GF, Gatto R, Tecco S. Short-Term Effect of Orthodontic Treatment with Clear Aligners on Pain and sEMG Activity of Masticatory Muscles. Medicina (Kaunas). 2021 Feb 19;57(2):178. doi: 10.3390/medicina57020178.
• Castroflorio T, Icardi K, Torsello F, Deregibus A, Debernardi C, Bracco P. Reproducibility of surface EMG in the human masseter and anterior temporalis muscle areas. Cranio. 2005 Apr;23(2):130-7. doi: 10.1179/crn.2005.018.
• Tepedino M, Colasante P, Staderini E, Masedu F, Ciavarella D. Short-term effect of orthodontic clear aligners on muscular activity and occlusal contacts: A cohort study. Am J Orthod Dentofacial Orthop. 2023 Jul;164(1):34-44. doi: 10.1016/j.ajodo.2022.10.025. Epub 2023 Mar 3.
• Erdem A, Kilic N, Eroz B. Changes in soft tissue profile and electromyographic activity after activator treatment. Aust Orthod J. 2009 Nov;25(2):116-22.
• Tande C, Hadi B, Chowdhury R, Subramanian S, Byamukama E. First Report of Sudden Death Syndrome of Soybean Caused by Fusarium virguliforme in South Dakota. Plant Dis. 2014 Jul;98(7):1012. doi: 10.1094/PDIS-01-14-0107-PDN.
• Castroflorio T, Bracco P, Farina D. Surface electromyography in the assessment of jaw elevator muscles. J Oral Rehabil. 2008 Aug;35(8):638-45. doi: 10.1111/j.1365-2842.2008.01864.x. Epub 2008 May 9.

Helpful Links

• The linked page explains the device used in the study (BioRadio)

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 3, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Masseter muscle; Clear aligner therapy; Muscular activity; Conventional fixed therapy; Anterior temporalis
• Other Study ID Numbers: sEMG in orthodontic treatment

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No