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

NCT ID: NCT06699290

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-31

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Masseter Muscle Activity Anterior Temporalis Muscle Activity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Clear aligner therapy group

No interventions assigned to this group

Conventional fixed therapy group

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riyadh Elm University

OTHER

Sponsor Role lead

Responsible Party

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Ali Mesfer Alshamrani

Principal investigator.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Riyadh Elm University

Riyadh, Riyadh Region, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Central Contacts

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Ali M Alshamrani, Bachelor degree in Dentistry.

Role: CONTACT

+966580111225

Facility Contacts

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Post graduate studies office, Masters degree in orthodontics

Role: primary

+966112100000

References

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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.

Reference Type BACKGROUND
PMID: 15898569 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33669677 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36870918 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20043545 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30708925 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18466277 (View on PubMed)

Related Links

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https://www.glneurotech.com/products/bioradio/

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

Other Identifiers

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sEMG in orthodontic treatment

Identifier Type: -

Identifier Source: org_study_id

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