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
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2020
CompletedFirst Submitted
Initial submission to the registry
November 29, 2023
CompletedFirst Posted
Study publicly available on registry
December 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedDecember 14, 2023
December 1, 2023
3.9 years
November 29, 2023
December 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
amount of upper first molar distal movement
mm/month
till achievement of class I molar relation, an average of 1 year
Study Arms (2)
Laser group
EXPERIMENTALcontrol group
ACTIVE COMPARATORInterventions
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
distal jet distalizing appliance is supported on two paramedian screw
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Al Azhar dental hospital
Cairo, Nasr City, 002, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rabab HF elhosseini, MSD
Al-Azhar University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSD of Orthodontics
Study Record Dates
First Submitted
November 29, 2023
First Posted
December 14, 2023
Study Start
February 20, 2020
Primary Completion
January 1, 2024
Study Completion
March 1, 2024
Last Updated
December 14, 2023
Record last verified: 2023-12