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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorRiyadh Elm University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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) .

Disqualifiers

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.

Trial population

Participants will be enrolled from Riyadh Elm University, Orthodontic Clinics, along with other private centers, Riyadh, Kingdom of Saudi Arabia.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 2 trial groups
Group A: Clear aligner therapy group
Group B: Conventional fixed therapy group

Trial outcomes

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: