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

Not yet recruiting

• Conditions: Masseter Muscle Activity; Anterior Temporalis Muscle Activity

• Registration Number: NCT06699290
• Lead Sponsor: Riyadh Elm University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-03
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-21
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-25
• Study Start: 2025-03
• Primary Completion: 2025-11
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of muscular activity in clear aligners vs conventional fixed orthodontic therapies at 3 months using the BioRadio sEMG device.	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.	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.

Trial Locations

Locations (1)

Riyadh Elm University; 🇸🇦 Riyadh, Saudi Arabia