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

NCT03251807 | Completed DMC

• 1 other identifier: UDDS-Ortho-06-2017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malocclusion, Angle Class II

Keywords

Low-intensity pulsed ultrasound; Twin-block; Functional treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Dentoskeletal effects of the functional treatment

  Changes will be evaluated before and after functional treatment which will take approximately 8 months

Study Arms (2)

Twin-block

EXPERIMENTAL

The patients in this control group will be treated using the Twin-block appliance.

Device: Twin-block

Twin-block combined with LIPUS

EXPERIMENTAL

The patients in this experimental group will be treated using the Twin-block combined with LIPUS (Low-intensity pulsed ultrasound).

Device: Twin-block; Other: LIPUS (Low-intensity pulsed ultrasound)

Interventions

Twin-block DEVICE

Functional treatment will be achieved using the Twinblock appliance

Twin-block; Twin-block combined with LIPUS

LIPUS (Low-intensity pulsed ultrasound) OTHER

Functional treatment will be combined with LIPUS (Low-intensity pulsed ultrasound )

Twin-block combined with LIPUS

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, 00963, Syria

Location

Related Publications (6)

• 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.

  PMID: 14719726 BACKGROUND

• 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.

  PMID: 17045140 BACKGROUND

• 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.

  PMID: 16808582 BACKGROUND

• 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.

  PMID: 17110256 BACKGROUND

• 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.

  PMID: 17207688 BACKGROUND

• 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.

  PMID: 11523040 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Ultrasonic Waves

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Ghiath Mahmood, PhD.

  Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2017
• First Posted: August 16, 2017
• Study Start: August 1, 2017
• Primary Completion: October 12, 2018
• Study Completion: March 12, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)