An Electromyography Study Comparing the Impact of Using RMEs on Muscle Activity Among Growing Orthodontic Patients
NCT ID: NCT02752347
Last Updated: 2017-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
50 participants
INTERVENTIONAL
2016-04-30
2017-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Two channels surface Electromyography sEMG (BioRadio), will be position to record the activity of anterior temporal (AT) and masseter (MM) muscles in three different statuses:
* Rest → patients will instruct to not bite on his/her teeth.
* Clench → patients will instruct to made a maximum voluntary clench on cotton rolls positioned around the first molar, for 5 sec "the cotton clench", and a maximum voluntary clench without the interposed rolls for 5 sec "the "clench".
\* This procedure followed the Sforza et al. protocol.
* During function "mastication" → The patients will instruct to chew on a chewing gum for 20 sec (20 continuous masticatory cycles).
Examination frequency:
The patients will be examined two times as follow:
Test 1: Immediately before rapid maxillary expanders cementation, Test 2: 5 months later (1 month after the retention phase).
the same procedure will be done on 35 patients (control group)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
unilateral crossbite
unilateral crossbite patients with constricted maxilla, going to be treated by rapid maxillary expanders the surface Electromyography (surface EMG device) device will be used to examine the muscle activities before and after expansion
Surface EMG device
measuring the muscles activity using surface EMG device
control
the surface Electromyography (surface EMG device) device will be used to examine the muscle activities on normal patients
No interventions assigned to this group
Bilateral crossbite
Bilateral crossbite patients with constricted maxilla, going to be treated by rapid maxillary expanders the surface Electromyography (surface EMG device) device will be used to examine the muscle activities before and after expansion
Surface EMG device
measuring the muscles activity using surface EMG device
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Surface EMG device
measuring the muscles activity using surface EMG device
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients with erupted permanent maxillary and mandibular first molars.
3. Will be treated by rapid maxillary expanders, (the appliance planning to be worn for approximately 5 months).
4. Age ranged from 9 to 12.
5. Males and females.
6. Not under any medications.
7. Skeletal Class I or Class II (based on ANB angle, convexity, and Wits appraisal).
8. No active caries.
9. Healthy periodontal tissues.
10. Subjects with no signs of TMD or condylar problems.
Exclusion Criteria
2. Oral, systemic disease or any syndromes.
3. Patients under any medications.
6\. Patients with symptoms of Temporomandibular disorders. 4. Neuropathic conditions. 5. Open and deep-bite.
9 Years
15 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Riyadh Colleges of Dentistry and Pharmacy
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nancy Ajwa
Resident
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hezekiah A Mosadomi, DMD
Role: STUDY_CHAIR
Riyadh Colleges of Dentistry and Pharmacy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Riyadh Colleges of Dentistry and Pharmacy
Riyadh, , Saudi Arabia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Hezekiah mosadomi, Prof
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FPGRP/43534001/14
Identifier Type: -
Identifier Source: org_study_id