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Two Low-level Laser Irradiation Protocols on the Rate of Canine Retraction

Primary Purpose

Malocclusion

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks
low-level laser therapy applied every 3 weeks
Sponsored by
Hams Hamed Abdelrahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion

Eligibility Criteria

15 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Malocclusion requires at least the extraction of maxillary first premolars, followed by canine retraction into the extraction site.
  • Normal shape and structure of the maxillary canines, with no history of root canal treatment.
  • Patients with good oral hygiene, and a healthy periodontal condition.

Exclusion Criteria:

  • Patients who underwent previous orthodontic treatment.
  • Patients currently receiving drug therapy that may affect orthodontic tooth movement, e.g. hormonal therapy and corticosteroids.
  • Patients with chronic diseases that may affect the rate of tooth movement.
  • Pregnancy and lactation

Sites / Locations

  • Alexandria Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks

low-level laser therapy applied every 3 weeks

Arm Description

Outcomes

Primary Outcome Measures

Change in rate of canine retraction
Several landmarks will be identified on the dental cast, including the mid-palatal raphe, the most medial points on the third right and left rugae, and the cusp tips of the right and left maxillary canines. Perpendicular lines will be drawn from the medial points of the right and left third rugae, and the cusp tips of the right and left maxillary canines to the mid-palatal raphe. The antero-posterior measurements will be carried out between the canine lines and the third rugae lines bilaterally, to assess the rate of canine retraction.
change in IL-1β level in the Ginigval Crevicular Fluid
Samples from the GCF will be collected at baseline (before the first canine retraction), in addition to days 7, 14, and 21. GCF samples will be collected from the distal crevices of the canines, in Groups A and B, on both the experimental and control sides. Measurement of IL-1β level in the GCF will be performed using an ELISA kit.

Secondary Outcome Measures

change canine root resorption:
Root resorption of the maxillary canines will be evaluated and measured on the acquired pre-retraction and post-retraction CBCT scans.
Change molar anchorage loss
Perpendicular lines will be drawn from the central fossae of both maxillary right and left first molars to the mid-palatal raphe. Consequently, molar anchorage loss will be calculated by measuring the distance between those lines, and the lines representing the third rugae as previously mentioned.

Full Information

First Posted
June 3, 2021
Last Updated
June 11, 2021
Sponsor
Hams Hamed Abdelrahman
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1. Study Identification

Unique Protocol Identification Number
NCT04926389
Brief Title
Two Low-level Laser Irradiation Protocols on the Rate of Canine Retraction
Official Title
The Effect of Two Low-level Laser Irradiation Protocols on the Rate of Canine Retraction (a Randomized Controlled Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 15, 2021 (Anticipated)
Study Completion Date
June 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Several methods aiming at the acceleration of orthodontic tooth movement have been proposed, including low-level laser therapy (LLLT), which showed promising results. However, the frequency of patient recall has been one of its major drawbacks.
Detailed Description
A randomized controlled clinical trial will be conducted to address the aim of the study. Sixteen patients will be recruited, requiring the therapeutic extraction of the maxillary 1st premolars, with subsequent canine retraction into the extraction space. The sample will be randomly divided into 2 equal groups, each including 8 subjects. In Group A, one side of the maxillary arch will randomly receive LLLT on days 0, 3, 7, 14, and every 2 weeks thereafter, while in Group B, one side will also be randomly chosen to receive LLLT every 3 weeks. The contralateral sides of both groups will serve as the controls. The LLLT applied will be Diode laser emitting infrared radiation at wavelength of 980 nm, in a continuous mode. Canine retraction in both groups will be carried out bilaterally using nickel-titanium closed-coil spring, delivering 150 grams of force, and the rate of tooth movement will be checked every 3 weeks, over a period of 3 months. Other variables will be also examined including, interleukin-1β level in the gingival crevicular fluid, root resorption, and molar anchorage loss.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks
Arm Type
Experimental
Arm Title
low-level laser therapy applied every 3 weeks
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks
Intervention Description
one side of the maxillary arch will randomly receive LLLT on days 0, 3, 7, 14, and every 2 weeks thereafter and the contralateral side will serve as the controls.
Intervention Type
Other
Intervention Name(s)
low-level laser therapy applied every 3 weeks
Intervention Description
one side will also be randomly chosen to receive LLLT every 3 weeks and the contralateral side will serve as the controls.
Primary Outcome Measure Information:
Title
Change in rate of canine retraction
Description
Several landmarks will be identified on the dental cast, including the mid-palatal raphe, the most medial points on the third right and left rugae, and the cusp tips of the right and left maxillary canines. Perpendicular lines will be drawn from the medial points of the right and left third rugae, and the cusp tips of the right and left maxillary canines to the mid-palatal raphe. The antero-posterior measurements will be carried out between the canine lines and the third rugae lines bilaterally, to assess the rate of canine retraction.
Time Frame
at baseline and every 3 weeks for 3 months
Title
change in IL-1β level in the Ginigval Crevicular Fluid
Description
Samples from the GCF will be collected at baseline (before the first canine retraction), in addition to days 7, 14, and 21. GCF samples will be collected from the distal crevices of the canines, in Groups A and B, on both the experimental and control sides. Measurement of IL-1β level in the GCF will be performed using an ELISA kit.
Time Frame
at baseline, 7th, 17th and 21st day
Secondary Outcome Measure Information:
Title
change canine root resorption:
Description
Root resorption of the maxillary canines will be evaluated and measured on the acquired pre-retraction and post-retraction CBCT scans.
Time Frame
at baseline and 3 months
Title
Change molar anchorage loss
Description
Perpendicular lines will be drawn from the central fossae of both maxillary right and left first molars to the mid-palatal raphe. Consequently, molar anchorage loss will be calculated by measuring the distance between those lines, and the lines representing the third rugae as previously mentioned.
Time Frame
at baseline and every 3 weeks for 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Malocclusion requires at least the extraction of maxillary first premolars, followed by canine retraction into the extraction site. Normal shape and structure of the maxillary canines, with no history of root canal treatment. Patients with good oral hygiene, and a healthy periodontal condition. Exclusion Criteria: Patients who underwent previous orthodontic treatment. Patients currently receiving drug therapy that may affect orthodontic tooth movement, e.g. hormonal therapy and corticosteroids. Patients with chronic diseases that may affect the rate of tooth movement. Pregnancy and lactation
Facility Information:
Facility Name
Alexandria Faculty of Dentistry
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
35659655
Citation
Eid FY, El-Kenany WA, Mowafy MI, El-Kalza AR. The influence of two photobiomodulation protocols on orthodontically induced inflammatory root resorption (a randomized controlled clinical trial). BMC Oral Health. 2022 Jun 5;22(1):221. doi: 10.1186/s12903-022-02251-w.
Results Reference
derived

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Two Low-level Laser Irradiation Protocols on the Rate of Canine Retraction

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