The Effect of Low-level Laser Therapy on Functional Treatment of Skeletal Class II Patients

March 11, 2024 updated by: Nada Gaballah, Mansoura University
this is a controlled clinical trial with 2 groups of patients of class II skeletal discrepancy due to mandibular retrusion one group is treated with twin block functional appliance and the other with twin block combined with low level laser therapy ,the study aims to detect the effect of low level laser on the skeletal outcomes , dentoalveolar outcomes, rate of correction and pain during treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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

  • Egypt
    • Dakahleya
      • Mansoura, Dakahleya, Egypt, 35511
        • Faculty of Dentistry

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

No

Description

Inclusion Criteria:

  • Age (early permanent dentition)
  • Cervical maturation stage CS 3-4
  • Skeletal class II due to mandibular retrusion.
  • Overjet more than 4mm.

Exclusion Criteria:

  • Cleft lip or palate.
  • Systemic diseases.
  • Previous orthodontic treatment or abnormal habits.
  • Congenital craniofacial deformity.
  • poor oral hygiene

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
Experimental: twin block
group treated with twin block only
Other: twin block
2 parallel groups one is treated with twin block and the other is treated with twin block combined with low level laser therapy
Experimental: twin block combined with low level laser
group treated with twin block combined with low level laser therapy
Other: twin block combined with low level laser
2 parallel groups one is treated with twin block and the other is treated with twin block combined with low level laser therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment time
Time Frame: 8 months
comparison of treatment between the 2 different groups
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cephalometric measurements
Time Frame: 8 months
digital tracing of pre and post treatment cephalograms of both groups and comparison of linear and angular measurements
8 months
study cast analysis
Time Frame: 8 months
cast analysis of both groups measuring arch perimeter , intercanine wisth and intermolar width
8 months
the short form McGill pain questionnaire
Time Frame: 1 month
comparison of questionnaire results between the 2 groups
1 month

Collaborators and Investigators

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

Sponsor

Mansoura 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)

October 26, 2022

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dentist.1995

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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