Assessment of Low Level Laser Therapy Effect on Treatment Outcomes of Bony Supported Distal Jet for Correction of Angle Class II Malocclusion (Randomized Clinical Trial) (LLLT)

December 6, 2023 updated by: Rabab Abdel Hafez El Hosseini, Faculty of Dental Medicine for Girls

The goal of this randomized clinical trial is to compare the effect of LLLT in adolescent patient with class II malocclusion. The main question it aims to answer is:

• is there a difference in the amount of distalization between laser and control groups? Participants will received bony supported distal jet. Researchers will compare laser group with control group to see if there is a difference in amount of distalization between groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of the present study is to assess the effect of low level laser therapy on treatment outcomes of bony supported distal jet for correction of 20 orthodontic patients with angle class II malocclusion. enrolled patient is randomly divided into 2 groups laser group and distal screw group. for result assessment dental casts and CBCT are taken before and after completion of distalization. both groups receives Distal Jet supported on 2 paramedian screw with laser therapy for laser group only.

Study Type

Interventional

Enrollment (Estimated)

20

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 Contact

Study Locations

  • Egypt
    • Nasr City
      • Cairo, Nasr City, Egypt, 002
        • Recruiting
        • Al Azhar dental hospital
        • Contact:
        • Principal Investigator:
          • Rabab HF elhossieni, MSD

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • bilateral Angle's Class II malocclusion minimum of 1/4 cusp discrepancy, normal or low mandibular plane (MP) angle cases and no history of serious medical illness

Exclusion Criteria:

  • subjects with skeletal Class II with retrusion mandibular profile, vertical growth pattern and steep mandibular plane angle and subjects with shallow or anterior open bite.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
Device: bonny supported distal jet
distal jet distalizing appliance is supported on two paramedian screw
Experimental: Laser group
Radiation: low level laser therapy
irradiation with LLLT by the following regimen 0, 3, 7 and 14 from the activation of the bony supported Distal Jet and then every 15 days till completion of distalization
Device: bonny supported distal jet
distal jet distalizing appliance is supported on two paramedian screw

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of upper first molar distal movement
Time Frame: till achievement of class I molar relation, an average of 1 year
mm/month
till achievement of class I molar relation, an average of 1 year

Collaborators and Investigators

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

Sponsor

Faculty of Dental Medicine for Girls

Investigators

  • Principal Investigator: Rabab HF elhosseini, MSD, Al-Azhar University

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)

February 20, 2020

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Actual)

December 14, 2023

Study Record Updates

Last Update Posted (Actual)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-OR-19-01

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.

Clinical Trials on This Study Focus on the Effect of Low-Level Light Therapy on the Amount of Upper Molar Distalization

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