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

Primary Purpose

Malocclusion, Angle Class II

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Twin-block
LIPUS (Low-intensity pulsed ultrasound)
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class II focused on measuring Low-intensity pulsed ultrasound, Twin-block, Functional treatment

Eligibility Criteria

11 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Damascus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Twin-block

Twin-block combined with LIPUS

Arm Description

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

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

Outcomes

Primary Outcome Measures

The duration of functional treatment
The duration of the functional treatment will be measured and compared between groups.

Secondary Outcome Measures

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.

Full Information

First Posted
August 13, 2017
Last Updated
July 16, 2019
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT03251807
Brief Title
Effect of Low-Intensity Pulsed Ultrasound on Functional Treatment of Class II Malocclusion
Official Title
Effect of Low-Intensity Pulsed Ultrasound Applied on Temporomandibular Joint Region on Functional Treatment of Class II Malocclusion: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
October 12, 2018 (Actual)
Study Completion Date
March 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class II
Keywords
Low-intensity pulsed ultrasound, Twin-block, Functional treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Twin-block
Arm Type
Experimental
Arm Description
The patients in this control group will be treated using the Twin-block appliance.
Arm Title
Twin-block combined with LIPUS
Arm Type
Experimental
Arm Description
The patients in this experimental group will be treated using the Twin-block combined with LIPUS (Low-intensity pulsed ultrasound).
Intervention Type
Device
Intervention Name(s)
Twin-block
Intervention Description
Functional treatment will be achieved using the Twinblock appliance
Intervention Type
Other
Intervention Name(s)
LIPUS (Low-intensity pulsed ultrasound)
Intervention Description
Functional treatment will be combined with LIPUS (Low-intensity pulsed ultrasound )
Primary Outcome Measure Information:
Title
The duration of functional treatment
Description
The duration of the functional treatment will be measured and compared between groups.
Time Frame
After functional treatment which will take approximately 8 months
Secondary Outcome Measure Information:
Title
Dentoskeletal effects of the functional treatment
Description
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.
Time Frame
Changes will be evaluated before and after functional treatment which will take approximately 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghiath Mahmood, PhD.
Organizational Affiliation
Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
Official's Role
Study Director
Facility Information:
Facility Name
Damascus University
City
Damascus
ZIP/Postal Code
00963
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University
Citations:
PubMed Identifier
14719726
Citation
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.
Results Reference
background
PubMed Identifier
17045140
Citation
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.
Results Reference
background
PubMed Identifier
16808582
Citation
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.
Results Reference
background
PubMed Identifier
17110256
Citation
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.
Results Reference
background
PubMed Identifier
17207688
Citation
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.
Results Reference
background
PubMed Identifier
11523040
Citation
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.
Results Reference
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Effect of Low-Intensity Pulsed Ultrasound on Functional Treatment of Class II Malocclusion

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