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Status unknownNCT02752347Updated Oct 9, 2017

An Electromyography Study Comparing the Impact of Using RMEs on Muscle Activity Among Growing Orthodontic Patients

An interventional study of Surface EMG device in Malocclusion, sponsored by Riyadh Colleges of Dentistry and Pharmacy. Status unknown at 1 site in Saudi Arabia. Open to participants aged 9 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-09.

Sponsored by Riyadh Colleges of Dentistry and Pharmacy · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
9 Years to 15 Years
Sex
All
01

Study 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 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)

02

Conditions studied

  • Malocclusion

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03

In context

Malocclusion

469 studies on the registry are indexed under Malocclusion; 91 are open to participants now.

This study's planned enrollment of 50 is above the median of 36 across 383 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Riyadh Colleges of Dentistry and Pharmacy is the lead sponsor of 28 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Uni-lateral/ or bilateral posterior cross-bite.
  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

Exclusion Criteria:

  1. History of any functional appliance treatment.
  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.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    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

    Device: Surface EMG device

  • No intervention
    control

    the surface Electromyography (surface EMG device) device will be used to examine the muscle activities on normal patients

  • Experimental
    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

    Device: Surface EMG device

Interventions

  • DeviceSurface EMG device

    measuring the muscles activity using surface EMG device

    Also known as: BioRadio EMG Device

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Test 1: before cementation of rapid maxillary expander, Test 2: after removal of rapid maxillary expander by 1 month

07

Study locations

1 of 1 sites recruiting
  • Riyadh Colleges of Dentistry and Pharmacy
    Riyadh, 11681, Saudi Arabia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — data will be used for a research purpose only , will not be shared with any other institution

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2016, a primary completion of Jun 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 15, 2016
First posted
Apr 27, 2016
Start
Apr 2016
Primary completionActual
Jun 2017
CompletionEst.
Dec 30, 2017
Last update
Oct 9, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02752347
Lead sponsor
Riyadh Colleges of Dentistry and Pharmacy
Responsible party
Nancy Ajwa (Resident, Riyadh Colleges of Dentistry and Pharmacy) — Principal investigator
First posted
Apr 27, 2016
Start date
Apr 2016
Primary completion
Jun 2017
Completion
Dec 30, 2017 (estimated)
Last update
Oct 9, 2017

Study contacts

Nancy Ajwa, Residant
Contact
nancy.ajwa@student.riyadh.edu.sa
0554804564
Hezekiah A Mosadomi, DMD
study chair · Riyadh Colleges of Dentistry and Pharmacy

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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