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

NCT02752347 | Unknown DMC

• 1 other identifier: FPGRP/43534001/14
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion

Outcome Measures

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

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

Study Arms (3)

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

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

Device: Surface EMG device

Interventions

Surface EMG device DEVICE

measuring the muscles activity using surface EMG device

Also known as: BioRadio EMG Device

Bilateral crossbite; unilateral crossbite

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• History of any functional appliance treatment.
• Oral, systemic disease or any syndromes.
• Patients under any medications.
• \. Patients with symptoms of Temporomandibular disorders. 4. Neuropathic conditions. 5. Open and deep-bite.

Sponsors & Collaborators

• Riyadh Colleges of Dentistry and Pharmacy: lead

Study Sites (1)

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, 11681, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Hezekiah A Mosadomi, DMD

  Riyadh Colleges of Dentistry and Pharmacy

  STUDY CHAIR

Central Study Contacts

Nancy Ajwa, Residant

CONTACT

0554804564; nancy.ajwa@student.riyadh.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 27, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: December 30, 2017
• Last Updated: October 9, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)