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

Primary Purpose

Malocclusion

Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Surface EMG device
Sponsored by
Riyadh Colleges of Dentistry and Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malocclusion

Eligibility Criteria

9 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Riyadh Colleges of Dentistry and PharmacyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

unilateral crossbite

control

Bilateral crossbite

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 15, 2016
Last Updated
October 6, 2017
Sponsor
Riyadh Colleges of Dentistry and Pharmacy
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1. Study Identification

Unique Protocol Identification Number
NCT02752347
Brief Title
An Electromyography Study Comparing the Impact of Using RMEs on Muscle Activity Among Growing Orthodontic Patients
Official Title
An Electromyography Study Comparing the Impact of Using RMEs on Muscle Activity Among Growing Orthodontic Patients (A Prospective Clinical Study)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 30, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riyadh Colleges of Dentistry and Pharmacy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
unilateral crossbite
Arm Type
Experimental
Arm Description
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
Arm Title
control
Arm Type
No Intervention
Arm Description
the surface Electromyography (surface EMG device) device will be used to examine the muscle activities on normal patients
Arm Title
Bilateral crossbite
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Surface EMG device
Other Intervention Name(s)
BioRadio EMG Device
Intervention Description
measuring the muscles activity using surface EMG device
Primary Outcome Measure Information:
Title
measuring the masticatory muscles activity using electromyography device
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Ajwa, Residant
Phone
0554804564
Email
nancy.ajwa@student.riyadh.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hezekiah A Mosadomi, DMD
Organizational Affiliation
Riyadh Colleges of Dentistry and Pharmacy
Official's Role
Study Chair
Facility Information:
Facility Name
Riyadh Colleges of Dentistry and Pharmacy
City
Riyadh
ZIP/Postal Code
11681
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hezekiah mosadomi, Prof
Phone
00966509995087
Email
prof.mosadomi@riyadh.edu.sa

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
data will be used for a research purpose only , will not be shared with any other institution

Learn more about this trial

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

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