Riyadh Elm University
Riyadh, Riyadh Region, 12734, Saudi Arabia
Location contact
Post graduate studies office, Masters degree in orthodontics
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Not Yet Recruiting
NCT Number: NCT06699290
Orthodontic Clear Aligners Vs Conventional Fixed Appliance's Impact on Muscular Activities Among Adults Using SEMG (Surface Electromyography)
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
16 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
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.
Muscle activity will be recorded using the BioRadio device in four statuses:
- Rest
- Clenching 1: participants will be asked to apply maximum voluntary clenching MVC
- Clenching 2: participants will be asked to apply MVC on a standardized cotton roll.
- Mastication: participants will be instructed to chew on a standardized sugar free chewing gum.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Riyadh Elm University
Other
Registry information
Official study title
An Orthodontic Clear Aligners Vs Conventional Fixed Appliances Impact on Muscular Activities Among Adults: a Surface Electromyography (sEMG) Prospective Comparative Study
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Nov 21, 2024
- Registry last updated
- Nov 25, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.