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

NCT06699290 | Not Yet Recruiting DMC

• 1 other identifier: sEMG in orthodontic treatment
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Masseter Muscle Activity; Anterior Temporalis Muscle Activity

Keywords

Muscular activity; Clear aligner therapy; Conventional fixed therapy; Anterior temporalis; Masseter muscle

Outcome Measures

Primary Outcomes (1)

• 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: 1. Rest 2. Clenching 1: participants will be asked to apply maximum voluntary clenching MVC 3. Clenching 2: participants will be asked to apply MVC on a standardized cotton roll. 4. 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.

Study Arms (2)

Clear aligner therapy group

Conventional fixed therapy group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riyadh Elm University: lead

Study Sites (1)

Riyadh Elm University

Riyadh, Riyadh Region, 12734, Saudi Arabia

Location

Related Publications (6)

• 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.

  PMID: 15898569 BACKGROUND

• 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.

  PMID: 33669677 BACKGROUND

• 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.

  PMID: 36870918 BACKGROUND

• 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.

  PMID: 20043545 BACKGROUND

• 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.

  PMID: 30708925 BACKGROUND

• 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.

  PMID: 18466277 BACKGROUND

Related Links

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

Central Study Contacts

Ali M Alshamrani, Bachelor degree in Dentistry.

CONTACT

+966580111225; ali.m.alshamrani2023@student.riyadh.edu.sa

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator.

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 21, 2024
• Study Start: March 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

SA (1)