Treatment of Class II Malocclusion Combined With Low-level Laser

July 16, 2019 updated by: Damascus University

The Effects of Combined Treatment With Low-level Laser and Functional Appliances on the Correction of Class II Malocclusion: A Randomized Controlled Trial

This experimental study will evaluate the effect of combined treatment with low-level laser 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: a control group and an experimental group.

Functional appliance (twin-block) will be applied for all patients. Low-level laser 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Class II malocclusion is considered as the most common malocclusion between patients.

Recently low-level laser enters the world of dentistry, some studies assessed the effect of low-level laser on the growth of mandibles and condyles in animals and showed that there is a good effect of laser on the mandible growth.

This study will evaluate the effect of low-level laser on the growth of the mandible and the duration of functional treatment.

Twin-block will be applied in two groups: The control group will receive the twin-block only, and the experimental group will receive the twin-block combined with low-level laser therapy on the TMG region.

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Skeletal Class II malocclusion because of mandibular retrognathia
  • ANB > 4
  • Overjet > 5
  • SNB < 78

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Twin-block group
Functional treatment will be applied using the Twin-block appliance.
Device: Twin-block appliance
Functional treatment will be achieved using the Twin-block appliance
Experimental: Twin-block combined with low level laser
Functional treatment will be applied using the Twin-block appliance combined with low level laser.
Device: Twin-block appliance
Functional treatment will be achieved using the Twin-block appliance
Other: Low level laser
Functional treatment will be combined with low-level laser therapy on the TMG region

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After functional treatment which will take approximately 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Changes will be evaluated before and after functional treatment which will take approximately 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2017

Primary Completion (Actual)

October 15, 2018

Study Completion (Actual)

February 15, 2019

Study Registration Dates

First Submitted

July 28, 2017

First Submitted That Met QC Criteria

August 3, 2017

First Posted (Actual)

August 4, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Ortho-05-2017

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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