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Effect of Low Level Laser Therapy on Root Resorption During Orthodontic Intrusion of Maxillary Incisors

Primary Purpose

Root Resorption of Maxillary Incisors

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
gallium aluminum arsenide (Ga-Al-As) semiconductor diode laser (SMARTTM PRO, LASOTRONIX, Poland)
group B
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Root Resorption of Maxillary Incisors

Eligibility Criteria

12 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients with age range between 12-16 years. Overbite > 40% indicated for maxillary intrusion. Mild to moderate crowding of upper incisors. All permanent teeth erupted (excluding 3rd molars). No previous orthodontic treatment. Good oral hygiene with no previous periodontal surgery Exclusion Criteria: Transverse and/or vertical skeletal dysplasia or craniofacial malformation. Retained primary or missing permanent teeth in the maxillary anterior area, and any kind of tooth/root shape anomaly. Patients with root resorption, impacted canines, or dental anomalies. Poor oral hygiene Present or history of periodontal diseases. Systemic diseases or regular use of medications that could interfere with orthodontic tooth movement. History of trauma affecting the maxillary incisors. Endodontically treated upper anterior teeth.

Sites / Locations

  • Al Azhar Univertsity

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

Will includes 9 patients who will receive intrusive arche after leveling and alignment assisted with laser with wavelength 635 nm, 6.5J/cm2,The laser will be applied to 4 points of application for each tooth two labial and two palatal started immediately after first intrusive wire then at days 3,7,14 and then every 15 day until achievement of the study objectives

Will includes 9 patients who will receive intrusive arches after leveling and alignment without laser application

Outcomes

Primary Outcome Measures

linear amount of root resorption
cone beam computed linear measurements
volumetric amount of root resorption
cone beam computed volumetric measurements

Secondary Outcome Measures

Full Information

First Posted
November 22, 2022
Last Updated
January 28, 2023
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05707416
Brief Title
Effect of Low Level Laser Therapy on Root Resorption During Orthodontic Intrusion of Maxillary Incisors
Official Title
Effect of Low Level Laser Therapy on Root Resorption During Orthodontic Intrusion of Maxillary Incisors: A Comparative Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar 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
The present study will be directed to evaluate the effect of low-level laser therapy on root resorption during orthodontic intrusion of upper incisors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Resorption of Maxillary Incisors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Active Comparator
Arm Description
Will includes 9 patients who will receive intrusive arche after leveling and alignment assisted with laser with wavelength 635 nm, 6.5J/cm2,The laser will be applied to 4 points of application for each tooth two labial and two palatal started immediately after first intrusive wire then at days 3,7,14 and then every 15 day until achievement of the study objectives
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Will includes 9 patients who will receive intrusive arches after leveling and alignment without laser application
Intervention Type
Device
Intervention Name(s)
gallium aluminum arsenide (Ga-Al-As) semiconductor diode laser (SMARTTM PRO, LASOTRONIX, Poland)
Intervention Description
The laser will be applied to 4 points of application for each tooth two labial and two palatal started immediately after first intrusive wire then at days 3,7,14 and then every 15 day until achievement of the study objectives
Intervention Type
Other
Intervention Name(s)
group B
Intervention Description
Will includes 9 patients who will receive intrusive arches after leveling and alignment without laser application
Primary Outcome Measure Information:
Title
linear amount of root resorption
Description
cone beam computed linear measurements
Time Frame
change in linear root resorption at 4 months
Title
volumetric amount of root resorption
Description
cone beam computed volumetric measurements
Time Frame
change in volumetric root resorption at 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with age range between 12-16 years. Overbite > 40% indicated for maxillary intrusion. Mild to moderate crowding of upper incisors. All permanent teeth erupted (excluding 3rd molars). No previous orthodontic treatment. Good oral hygiene with no previous periodontal surgery Exclusion Criteria: Transverse and/or vertical skeletal dysplasia or craniofacial malformation. Retained primary or missing permanent teeth in the maxillary anterior area, and any kind of tooth/root shape anomaly. Patients with root resorption, impacted canines, or dental anomalies. Poor oral hygiene Present or history of periodontal diseases. Systemic diseases or regular use of medications that could interfere with orthodontic tooth movement. History of trauma affecting the maxillary incisors. Endodontically treated upper anterior teeth.
Facility Information:
Facility Name
Al Azhar Univertsity
City
Naşr
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25737942
Citation
Goel P, Tandon R, Agrawal KK. A comparative study of different intrusion methods and their effect on maxillary incisors. J Oral Biol Craniofac Res. 2014 Sep-Dec;4(3):186-91. doi: 10.1016/j.jobcr.2014.11.007. Epub 2014 Dec 6.
Results Reference
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Effect of Low Level Laser Therapy on Root Resorption During Orthodontic Intrusion of Maxillary Incisors

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