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

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.

Study Overview

• Status: Unknown
• Conditions: Malocclusion
• Intervention / Treatment: Device: Surface EMG 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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nancy Ajwa, Residant; Phone Number: 0554804564; Email: nancy.ajwa@student.riyadh.edu.sa

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11681
    • Recruiting
    • Riyadh Colleges of Dentistry and Pharmacy
    • Contact: Hezekiah mosadomi, Prof; Phone Number: 00966509995087; Email: prof.mosadomi@riyadh.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 15 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; measuring the muscles activity using surface EMG device; Other Names: BioRadio 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; measuring the muscles activity using surface EMG device; Other Names: BioRadio EMG Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Test 1: before cementation of rapid maxillary expander, Test 2: after removal of rapid maxillary expander by 1 month

Collaborators and Investigators

• Sponsor: Riyadh Colleges of Dentistry and Pharmacy

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ANTICIPATED): December 30, 2017

Study Registration Dates

• First Submitted: April 15, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (ESTIMATE): April 27, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 9, 2017
• Last Update Submitted That Met QC Criteria: October 6, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: FPGRP/43534001/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data will be used for a research purpose only , will not be shared with any other institution