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

Primary Purpose

Class II Malocclusion

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
twin block
twin block combined with low level laser
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Malocclusion focused on measuring twin block , functional appliance , low level laser , photobiomodulation

Eligibility Criteria

9 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

twin block

twin block combined with low level laser

Arm Description

group treated with twin block only

group treated with twin block combined with low level laser therapy

Outcomes

Primary Outcome Measures

treatment time
comparison of treatment between the 2 different groups

Secondary Outcome Measures

cephalometric measurements
digital tracing of pre and post treatment cephalograms of both groups and comparison of linear and angular measurements
study cast analysis
cast analysis of both groups measuring arch perimeter , intercanine wisth and intermolar width
the short form McGill pain questionnaire
comparison of questionnaire results between the 2 groups

Full Information

First Posted
August 23, 2023
Last Updated
September 5, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT06024382
Brief Title
The Effect of Low-level Laser Therapy on Functional Treatment of Skeletal Class II Patients
Official Title
The Effect of Low-level Laser Therapy on Functional Treatment of Skeletal Class II Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Malocclusion
Keywords
twin block , functional appliance , low level laser , photobiomodulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
twin block
Arm Type
Experimental
Arm Description
group treated with twin block only
Arm Title
twin block combined with low level laser
Arm Type
Experimental
Arm Description
group treated with twin block combined with low level laser therapy
Intervention Type
Other
Intervention Name(s)
twin block
Intervention Description
2 parallel groups one is treated with twin block and the other is treated with twin block combined with low level laser therapy
Intervention Type
Other
Intervention Name(s)
twin block combined with low level laser
Intervention Description
2 parallel groups one is treated with twin block and the other is treated with twin block combined with low level laser therapy
Primary Outcome Measure Information:
Title
treatment time
Description
comparison of treatment between the 2 different groups
Time Frame
8 months
Secondary Outcome Measure Information:
Title
cephalometric measurements
Description
digital tracing of pre and post treatment cephalograms of both groups and comparison of linear and angular measurements
Time Frame
8 months
Title
study cast analysis
Description
cast analysis of both groups measuring arch perimeter , intercanine wisth and intermolar width
Time Frame
8 months
Title
the short form McGill pain questionnaire
Description
comparison of questionnaire results between the 2 groups
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nada Gaballah, BDS
Phone
01063632718
Ext
002
Email
nadaessam@mans.edu.eg
Facility Information:
Facility Name
Faculty of Dentistry
City
Mansoura
State/Province
Dakahleya
ZIP/Postal Code
35511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nada Gaballah, BDS
Phone
01063632718
Ext
002
Email
nadaessam@mans.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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