Orthodontic Clear Aligners Vs Conventional Fixed Appliance's Impact on Muscular Activities Among … (NCT06699290) | Clinical Trial Compass
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Orthodontic Clear Aligners Vs Conventional Fixed Appliance's Impact on Muscular Activities Among Adults Using SEMG (Surface Electromyography)
Saudi Arabia60 participantsStarted 2025-03
Plain-language 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.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.