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

R

Riyadh Colleges of Dentistry and Pharmacy

Status

Unknown

Conditions

Malocclusion

Treatments

Device: Surface EMG device

Study type

Interventional

Funder types

Other

Identifiers

NCT02752347
FPGRP/43534001/14

Details and patient eligibility

About

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.

Full 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)

Enrollment

50 estimated patients

Sex

All

Ages

9 to 15 years old

Volunteers

Accepts 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.

  4. Patients with symptoms of Temporomandibular disorders. 4. Neuropathic conditions. 5. Open and deep-bite.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 3 patient groups

unilateral crossbite
Experimental group
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
Treatment:
Device: Surface EMG device
control
No Intervention group
Description:
the surface Electromyography (surface EMG device) device will be used to examine the muscle activities on normal patients
Bilateral crossbite
Experimental group
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
Treatment:
Device: Surface EMG device

Trial contacts and locations

1

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Central trial contact

Nancy Ajwa, Residant

Data sourced from clinicaltrials.gov

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