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Not yet recruitingNCT06699290Updated Nov 25, 2024

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

An observational study in Masseter Muscle Activity and Anterior Temporalis Muscle Activity, sponsored by Riyadh Elm University. Not yet recruiting at 1 site in Saudi Arabia. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-11-25.

Sponsored by Riyadh Elm University · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 1 year ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
16 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Masseter Muscle Activity
  • Anterior Temporalis Muscle Activity

Keywords

  • Muscular activity
  • Clear aligner therapy
  • Conventional fixed therapy
  • Anterior temporalis
  • Masseter muscle
03

In context

Lead sponsor

Riyadh Elm University is the lead sponsor of 26 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Clear aligner therapy group
  • Conventional fixed therapy group
06

What researchers measure

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.

    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.

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Study locations

1 site
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References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 18466277 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06699290
Lead sponsor
Riyadh Elm University
Responsible party
Ali Mesfer Alshamrani (Principal investigator., Riyadh Elm University) — Principal investigator
First posted
Nov 21, 2024
Start date
Mar 2025 (estimated)
Primary completion
Nov 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Nov 25, 2024

Study contacts

Ali M Alshamrani, Bachelor degree in Dentistry.
Contact
ali.m.alshamrani2023@student.riyadh.edu.sa
+966580111225

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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