ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03251807
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Damascus University

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.


Condition or disease Intervention/treatment Phase
Malocclusion, Angle Class II Device: Twin-block Other: LIPUS (Low-intensity pulsed ultrasound) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Low-Intensity Pulsed Ultrasound Applied on Temporomandibular Joint Region on Functional Treatment of Class II Malocclusion: A Randomized Controlled Trial
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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 )




Primary Outcome Measures :
  1. The duration of functional treatment [ Time Frame: After functional treatment which will take approximately 8 months ]
    The duration of the functional treatment will be measured and compared between groups.


Secondary Outcome Measures :
  1. Dentoskeletal effects of the functional treatment [ Time Frame: Changes will be evaluated before and after functional treatment which will take approximately 8 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03251807


Contacts
Contact: MHD Osama Namera, MSc. Student 99931066300963 osamanamera@gmail.com
Contact: Ghiath Mahmood , PhD. 00963944288289 ghiath@hotmail.com

Locations
Syrian Arab Republic
Damascus University Recruiting
Damascus, Syrian Arab Republic, 00963
Contact: Ahmad S Burhan, PhD    00963944302075    dr.burhan-a@hotmail.com   
Sponsors and Collaborators
Damascus University
Investigators
Study Director: Ghiath Mahmood , PhD. Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

Publications of Results:
Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT03251807     History of Changes
Other Study ID Numbers: UDDS-Ortho-06-2017
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Damascus University:
Low-intensity pulsed ultrasound
Twin-block
Functional treatment

Additional relevant MeSH terms:
Malocclusion
Malocclusion, Angle Class II
Overbite
Tooth Diseases
Stomatognathic Diseases