Clinical trial NCT06699290: Orthodontic Clear Aligners Vs Conventional Fixed Appliance's Impact on Muscular Activities Among Adults Using SEMG (Surface Electromyography)
Official title: An Orthodontic Clear Aligners Vs Conventional Fixed Appliances Impact on Muscular Activities Among Adults: a Surface Electromyography (sEMG) Prospective Comparative Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Masseter Muscle Activity
Anterior Temporalis Muscle Activity
Keywords: Muscular activity
Clear aligner therapy
Conventional fixed therapy
Anterior temporalis
Masseter muscle
Lead sponsor: Riyadh Elm University
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Changes of muscular activity in clear aligners vs conventional fixed orthodontic therapies at 3 months using the BioRadio sEMG device.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Riyadh Elm University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.