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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)

NCT ID: NCT06170099

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-20

Study Completion Date

2024-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Laser group

Group Type EXPERIMENTAL

low level laser therapy

Intervention Type RADIATION

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

bonny supported distal jet

Intervention Type DEVICE

distal jet distalizing appliance is supported on two paramedian screw

control group

Group Type ACTIVE_COMPARATOR

bonny supported distal jet

Intervention Type DEVICE

distal jet distalizing appliance is supported on two paramedian screw

Interventions

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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

Intervention Type RADIATION

bonny supported distal jet

distal jet distalizing appliance is supported on two paramedian screw

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Faculty of Dental Medicine for Girls

OTHER_GOV

Sponsor Role lead

Responsible Party

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Rabab Abdel Hafez El Hosseini

MSD of Orthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rabab HF elhosseini, MSD

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Locations

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Al Azhar dental hospital

Cairo, Nasr City, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Rabab HF elhosseini, MSD

Role: CONTACT

Phone: 01143376466

Email: [email protected]

Facility Contacts

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Rabab HF elhossieni, MSD

Role: primary

Other Identifiers

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REC-OR-19-01

Identifier Type: -

Identifier Source: org_study_id