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Not yet recruiting NCT06699290

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

— Observational Masseter Muscle Activity Anterior Temporalis Muscle Activity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Masseter Muscle Activity, Anterior Temporalis Muscle Activity. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Saudi Arabia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Changes of muscular activity in clear aligners vs conventional fixed orthodontic therapies at 3 months using the BioRadio sEMG device. [Time frame: 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Saudi Arabia · 1 center
  • Riyadh Elm University — Riyadh

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06699290 · sEMG in orthodontic treatment

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗