MalocclusionNCT02752347
An Electromyography Study Comparing the Impact of Using RMEs on Muscle Activity Among Growing Orthodontic Patients
A study testing Surface EMG device in people with Malocclusion, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
Trial summary
Compare the impact of using rapid maxillary expanders on masticatory muscle activities (Masseter and Anterior Temporalis muscles) among different posterior cross-bite patient (unilateral, bilateral) as well as compare the cross-bite side and non-cross-bite sides of the same preadolescent unilateral crossbite patient… Read more about this study
- Who is it for?
- Ages 9 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- Surface EMG device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Apr 2016to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Uni-lateral/ or bilateral posterior cross-bite.
- Patients with erupted permanent maxillary and mandibular first molars.
- Will be treated by rapid maxillary expanders, (the appliance planning to be worn for approximately 5 months).
- Age ranged from 9 to 12.
- Males and females.
- Not under any medications.
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- Skeletal Class I or Class II (based on ANB angle, convexity, and Wits appraisal).
- No active caries.
- Healthy periodontal tissues.
- Subjects with no signs of TMD or condylar problems.
Who cannot join
- History of any functional appliance treatment.
- Oral, systemic disease or any syndromes.
- Patients under any medications.
- 6. Patients with symptoms of Temporomandibular disorders. 4. Neuropathic conditions. 5. Open and deep-bite.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Riyadh Colleges of Dentistry and Pharmacy
Riyadh, 11681
Hezekiah mosadomi, Prof, 00966509995087, prof.mosadomi@riyadh.edu.sa
About this study
Official title: An Electromyography Study Comparing the Impact of Using RMEs on Muscle Activity Among Growing Orthodontic Patients (A Prospective Clinical Study)
Compare the impact of using rapid maxillary expanders on masticatory muscle activities (Masseter and Anterior Temporalis muscles) among different posterior cross-bite patient (unilateral, bilateral) as well as compare the cross-bite side and non-cross-bite sides of the same preadolescent unilateral crossbite patient before the expansion and after one month of the completion treatment period using surface electromyography device.
Read the detailed description
Compare the impact of using rapid maxillary expanders on masticatory muscle activities (Masseter and Anterior Temporalis muscles) between the cross-bite side and non-cross-bite sides of the same preadolescent orthodontic patient before the expansion and after one month of the completion treatment period.
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
- Malocclusion
- Being tested
- Surface EMG device
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface EMG deviceDevice
Also called BioRadio EMG Device
measuring the muscles activity using surface EMG device
| Study group | Role | What they receive |
|---|---|---|
| unilateral crossbite | Experimental | 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 Receives: Device: Surface EMG device |
| control | No intervention | the surface Electromyography (surface EMG device) device will be used to examine the muscle activities on normal patients |
| Bilateral crossbite | Experimental | 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 Receives: Device: Surface EMG device |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring the masticatory muscles activity using electromyography device
the muscle activities of masticatory muscles using surface Electromyography device before and compare it after the maxillary expansion using Rapid Maxillary Expanders (to study the impact of the expanders on the muscles), the muscle activity will be in form of micro volt/second (mV/sec), the data will aggregated then exported on excel sheet in a form of numbers for statistical analysis
Measured: Test 1: before cementation of rapid maxillary expander, Test 2: after removal of rapid maxillary expander by 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2017
- Study completion30 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Colleges of Dentistry and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Ajwa, Riyadh Colleges of Dentistry and Pharmacy
- Investigators
- Hezekiah A Mosadomi, DMD, Study chair, Riyadh Colleges of Dentistry and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752347
- Sponsor's protocol ID
- FPGRP/43534001/14
- Status last verified
- Oct 2017
- First submitted
- 15 Apr 2016
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: data will be used for a research purpose only , will not be shared with any other institution
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Electromyography Study Comparing the Impact of Using RMEs on Muscle Activity Among Growing Orthodontic Patients (A Prospective Clinical Study)
- ClinicalTrials.gov ID
- NCT02752347
- Acronym / sponsor ID
- FPGRP/43534001/14
- Conditions
- Malocclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riyadh Colleges of Dentistry and PharmacyUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- 30 Dec 2017 (estimated)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the impact of using rapid maxillary expanders on masticatory muscle activities (Masseter and Anterior Temporalis muscles) among different posterior cross-bite patient (unilateral, bilateral) as well as compare the cross-bite side and non-cross-bite sides of the same preadolescent unilateral crossbite patient before the expansion and after one month of the completion treatment period using surface electromyography device.
Detailed description
Compare the impact of using rapid maxillary expanders on masticatory muscle activities (Masseter and Anterior Temporalis muscles) between the cross-bite side and non-cross-bite sides of the same preadolescent orthodontic patient before the expansion and after one month of the completion treatment period.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| unilateral crossbite | Experimental | Device: Surface EMG deviceunilateral 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 |
| control | No intervention | –the surface Electromyography (surface EMG device) device will be used to examine the muscle activities on normal patients |
| Bilateral crossbite | Experimental | Device: Surface EMG deviceBilateral 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 |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Uni-lateral/ or bilateral posterior cross-bite.
- Patients with erupted permanent maxillary and mandibular first molars.
- Will be treated by rapid maxillary expanders, (the appliance planning to be worn for approximately 5 months).
- Age ranged from 9 to 12.
- Males and females.
Key exclusion criteria (4 listed)
- History of any functional appliance treatment.
- Oral, systemic disease or any syndromes.
- Patients under any medications.
- 6. Patients with symptoms of Temporomandibular disorders. 4. Neuropathic conditions. 5. Open and deep-bite.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surface EMG deviceAlso: BioRadio EMG Devicemeasuring the muscles activity using surface EMG device | Device | Bilateral crossbite, unilateral crossbite |
Primary outcome
measuring the masticatory muscles activity using electromyography device
Time frame: Test 1: before cementation of rapid maxillary expander, Test 2: after removal of rapid maxillary expander by 1 month
the muscle activities of masticatory muscles using surface Electromyography device before and compare it after the maxillary expansion using Rapid Maxillary Expanders (to study the impact of the expanders on the muscles), the muscle activity will be in form of micro volt/second (mV/sec), the data will aggregated then exported on excel sheet in a form of numbers for statistical analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Individual participant dataSharing planned: No. data will be used for a research purpose only , will not be shared with any other institution
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hezekiah A Mosadomi, DMD study chair
Riyadh Colleges of Dentistry and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surface EMG device in people with Malocclusion, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nancy Ajwa, Residant (0554804564, nancy.ajwa@student.riyadh.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring the masticatory muscles activity using electromyography device (time frame: Test 1: before cementation of rapid maxillary expander, Test 2: after removal of rapid maxillary expander by 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2017.