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

Malocclusion Clinical Trial

Official title:

The Effect of Two Low-level Laser Irradiation Protocols on the Rate of Canine Retraction (a Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04926389
• Other study ID #: Canine retraction 2020
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 15, 2021

Study information

• Verified date: June 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion

Intervention

Other:
• low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks
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.
• low-level laser therapy applied every 3 weeks
one side will also be randomly chosen to receive LLLT every 3 weeks and the contralateral side will serve as the controls.

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at baseline and every 3 weeks for 3 months
Primary	change in IL-1ß 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-1ß level in the GCF will be performed using an ELISA kit.	at baseline, 7th, 17th and 21st day
Secondary	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.	at baseline and 3 months
Secondary	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.	at baseline and every 3 weeks for 3 months