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RecruitingNCT06170099LLLTUpdated Dec 14, 2023

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)

An interventional study of low level laser therapy and bonny supported distal jet in This Study Focus on the Effect of Low-Level Light Therapy on the Amount of Upper Molar Distalization, sponsored by Faculty of Dental Medicine for Girls. Recruiting at 1 site in Egypt. Open to participants aged 10 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-14.

Sponsored by Faculty of Dental Medicine for Girls · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Registered 3 years 9 months after the study started (first participant enrolled Feb 2020, registered Nov 2023).
  • Started Feb 2020; still recruiting 6 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
10 Years to 14 Years
Sex
All
01

Study summary

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.
Read the 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.

02

Conditions studied

  • This Study Focus on the Effect of Low-Level Light Therapy on the Amount of Upper Molar Distalization
03

In context

Lead sponsor

Faculty of Dental Medicine for Girls is the lead sponsor of 54 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Laser group

    Radiation: low level laser therapy · Device: bonny supported distal jet

  • Active comparator
    control group

    Device: bonny supported distal jet

Interventions

  • Radiationlow 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

  • Devicebonny supported distal jet

    distal jet distalizing appliance is supported on two paramedian screw

06

What researchers measure

Primary outcomes

  1. amount of upper first molar distal movement

    mm/month

    Time frame: till achievement of class I molar relation, an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • Al Azhar dental hospital
    Cairo, Nasr City 002, Egypt
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2020 (actual). Primary completion is estimated for Jan 2024, 47 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2023
First posted
Dec 14, 2023
StartActual
Feb 20, 2020
Primary completionEst.
Jan 2024
CompletionEst.
Mar 2024
Last update
Dec 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06170099
Lead sponsor
Faculty of Dental Medicine for Girls
Responsible party
Rabab Abdel Hafez El Hosseini (MSD of Orthodontics, Azhar University) — Principal investigator
First posted
Dec 14, 2023
Start date
Feb 20, 2020
Primary completion
Jan 2024 (estimated)
Completion
Mar 2024 (estimated)
Last update
Dec 14, 2023

Study contacts

Rabab HF elhosseini, MSD
Contact
dr.rababelhosseny@yahoo.com
01143376466 ext. 002
Rabab HF elhosseini, MSD
principal investigator · Al-Azhar University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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