Effect of Low-Intensity Pulsed Ultrasound on Functional Treatment of Class II Malocclusion

Effect of Low-Intensity Pulsed Ultrasound Applied on Temporomandibular Joint Region on Functional Treatment of Class II Malocclusion: A Randomized Controlled Trial

This experimental study will evaluate the effect of combined treatment with low-intensity pulsed ultrasound (LIPUS) and functional appliances (twin-block) on the correction of class II malocclusion, compared with the control group treated with functional appliances (twin-block) only.

The study sample will consist of 40 patients with class II malocclusion. The sample will be allocated randomly into two groups: control group and experimental group.

The functional appliance (twin-block) will be applied for all patients, while the low-intensity pulsed ultrasound (LIPUS) will be applied for the experimental group only. The skeleto-dental changes occurring after functional treatment will be assessed using cephalometric radiographs; pre and post- treatment changes for each group will be evaluated individually, and the two groups will be compared.

Study Overview

• Status: Completed
• Conditions: Malocclusion, Angle Class II
• Intervention / Treatment: Device: Twin-block; Other: LIPUS (Low-intensity pulsed ultrasound)

Detailed Description

Studies of the etiologic factors of Class II malocclusions recognize that most Class II malocclusions are a result of mandibular deficiency and not of maxillary excess. For many patients, especially adults, optimal overall results are best obtained using a combined orthodontic-surgical approach. However, treating such cases early while the patient is still growing, using mandibular propulsive functional appliances, can produce satisfactory improvement in the facial esthetics, and minimizes the need for surgical intervention in many cases.

Ultrasound (US), a form of mechanical energy that is transmitted through and into biological tissues as an acoustic pressure wave at frequencies above the limit of human hearing, is used widely in medicine as a therapeutic, operative and diagnostic tool. Therapeutic US, and some operative US. Previous studies on animals have found that therapeutic ultrasound (US) can stimulate and enhance mandibular growth when applied during the active growth period.

This study will evaluate the effect of low-intensity pulsed ultrasound (LIPUS) on the growth of mandible and the duration of functional treatment.

Twin-block will be applied to the two groups. While the control group will receive the twin-block only, the experimental group will receive the twin-block combined with low-intensity pulsed ultrasound (LIPUS) on Temporomandibular joint (TMJ) region.

Cephalometric radiographs will be obtained before and after functional treatment to evaluate the dento-skeletal changes.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic, 00963
    • Damascus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Angle class II malocclusion because of mandibular retrognathia
• O.J > 5 , SNB < 78
• Patient during growth spurt

Exclusion Criteria:

• TMJ disorders
• Poor oral hygiene
• Previous orthodontic treatment.
• Patients with syndromes, clefts, or craniofacial abnormalities.
• Reason of contraindication of functional treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Twin-block; The patients in this control group will be treated using the Twin-block appliance.	Device: Twin-block; Functional treatment will be achieved using the Twinblock appliance
EXPERIMENTAL: Twin-block combined with LIPUS; The patients in this experimental group will be treated using the Twin-block combined with LIPUS (Low-intensity pulsed ultrasound).	Device: Twin-block; Functional treatment will be achieved using the Twinblock appliance; Other: LIPUS (Low-intensity pulsed ultrasound); Functional treatment will be combined with LIPUS (Low-intensity pulsed ultrasound )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration of functional treatment	The duration of the functional treatment will be measured and compared between groups.	After functional treatment which will take approximately 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dentoskeletal effects of the functional treatment	Dentoskeletal changes before and after functional treatment combined with Low-level Laser compared with those of the control group (SNA, SNB, ANB, Overjet ,…etc) using lateral cephalometric radiographs.	Changes will be evaluated before and after functional treatment which will take approximately 8 months

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Study Director: Ghiath Mahmood, PhD., Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

Publications and helpful links

General Publications

• El-Bialy T, El-Shamy I, Graber TM. Growth modification of the rabbit mandible using therapeutic ultrasound: is it possible to enhance functional appliance results? Angle Orthod. 2003 Dec;73(6):631-9. doi: 10.1043/0003-3219(2003)0732.0.CO;2.
• El-Bialy T, Hassan A, Albaghdadi T, Fouad HA, Maimani AR. Growth modification of the mandible with ultrasound in baboons: a preliminary report. Am J Orthod Dentofacial Orthop. 2006 Oct;130(4):435.e7-14. doi: 10.1016/j.ajodo.2006.01.025.
• Flores-Mir C, Major MP, Major PW. Soft tissue changes with fixed functional appliances in Class II division 1. Angle Orthod. 2006 Jul;76(4):712-20. doi: 10.1043/0003-3219(2006)076[0712:STCWFF]2.0.CO;2.
• Jena AK, Duggal R, Parkash H. Skeletal and dentoalveolar effects of Twin-block and bionator appliances in the treatment of Class II malocclusion: a comparative study. Am J Orthod Dentofacial Orthop. 2006 Nov;130(5):594-602. doi: 10.1016/j.ajodo.2005.02.025.
• Johns LD, Straub SJ, Howard SM. Analysis of effective radiating area, power, intensity, and field characteristics of ultrasound transducers. Arch Phys Med Rehabil. 2007 Jan;88(1):124-9. doi: 10.1016/j.apmr.2006.09.016.
• Sun JS, Hong RC, Chang WH, Chen LT, Lin FH, Liu HC. In vitro effects of low-intensity ultrasound stimulation on the bone cells. J Biomed Mater Res. 2001 Dec 5;57(3):449-56. doi: 10.1002/1097-4636(20011205)57:33.0.co;2-0.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2017
• Primary Completion (ACTUAL): October 12, 2018
• Study Completion (ACTUAL): March 12, 2019

Study Registration Dates

• First Submitted: August 13, 2017
• First Submitted That Met QC Criteria: August 13, 2017
• First Posted (ACTUAL): August 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 16, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Twin-block; Low-intensity pulsed ultrasound; Functional treatment
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: UDDS-Ortho-06-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No