Effect of Low Level Laser on Orthodontic Canine Retraction

Consequence of Two Protocols and Energy Doses of Low Level Laser Therapy on the Rate of Orthodontic Canine Retraction: A Prospective Clinical Evaluation

The aim of this study was to determine whether orthodontically moved maxillary canines exposed to two different protocols and dosage of LLLT exhibited differences in amount and rate of orthodontic tooth movement.

Study Overview

• Status: Completed
• Conditions: Dental Malocclusion
• Intervention / Treatment: Radiation: Low Level Laser Therapy

Detailed Description

Fifteen orthodontic patients, 12 females and 3males, with a mean age of 17.48 ± 2.95 years were included. They had a clinical indication for bilateral extraction of at least first maxillary premolars. Using a split mouth design, maxillary left and right sides were randomly divided into two groups. In group 1, LLLT was delivered at 10 points; 5 from buccal and 5 from palatal aspects with a total dose of 8 Joule (J) per session that distributed as follows; 2 cervical, 1 middle, 2 apical. In group II, laser was applied from buccal side only at 5 points through the same order with a dose of 4 J per session. In both protocols, maxillary canines were irradiated with a gallium aluminum-arsenide diode laser in continuous mode with 635 nm, 100 mW, 25 J/cm2, 8 seconds/ point, 0.8 J/point. Both sides were distalized by a standard protocol with uniform 150 gm retraction force via a nickel-titanium closed coil spring. In both protocols, laser regimen was applied on days 0, 3, 7, and 14 in the 1st month, and thereafter on every 15th day until 6-month observation period of canine retraction phase. Amount and monthly rate of maxillary canine retraction and degree of anchorage loss were determined by direct intraoral and indirect 3D digital models measurements. Evaluations were undertaken immediately before initiating retraction (T0), after 4 weeks (T1), after 8 weeks (T2), after 12 weeks (T3), after 16 weeks (T4), after 20 weeks (T5), and after 24 weeks (T6). Significance level was set at p < 0.05.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 25 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Complete permanent dentition (3rd molars excluded).
• The age was ranged from 15 -25 years.
• Malocclusion that required extraction of at least maxillary first premolars, followed by canine retraction.
• Good oral hygiene and periodontal health.

Exclusion Criteria:

• Patients who diagnosed to have an indication for non-extraction approach.
• Serious systemic diseases and/or long term medications that could interfere with OTM.
• Previous orthodontic treatment.
• Poor oral hygiene or periodontally compromised patients.
• Craniofacial anomalies or history of parafunctional habits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Buccal &palatal low level laser therapy; In group I,low level laser therapy was delivered at 10 points; 5 from buccal and 5 from palatal aspects with a total dose of 8 Joule (J) per session that distributed as follows; 2 cervical, 1 middle, 2 apical. Maxillary canines were irradiated with a gallium aluminum-arsenide diode laser in continuous mode with 635 nm, 100 mW, 25 J/cm2, 8 seconds/ point, 0.8 J/point.Maxillary canines were distalized by a standard protocol with uniform 150 gm retraction force via a nickel-titanium closed coil spring.Laser regimen was applied on days 0, 3, 7, and 14 in the 1st month, and thereafter on every 15th day until 6-month observation period of canine retraction phase.	Radiation: Low Level Laser Therapy; Other Names: Photobiomodulation
ACTIVE_COMPARATOR: Buccal low level laser therapy; In group II, low level laser therapy was delivered at 5 points; from buccal palatal aspects only with a total dose of 4 Joule (J) per session that distributed as follows; 2 cervical, 1 middle, 2 apical. Maxillary canines were irradiated with a gallium aluminum-arsenide diode laser in continuous mode with 635 nm, 100 mW, 25 J/cm2, 8 seconds/ point, 0.8 J/point.Maxillary canines were distalized by a standard protocol with uniform 150 gm retraction force via a nickel-titanium closed coil spring.Laser regimen was applied on days 0, 3, 7, and 14 in the 1st month, and thereafter on every 15th day until 6-month observation period of canine retraction phase.	Radiation: Low Level Laser Therapy; Other Names: Photobiomodulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation the rate of maxillary canine retraction	Evaluation and comparison of amount and monthly rate of distal movement of maxillary canine, in both groups, that were determined by direct intraoral measurements and indirect measurements of 3D scanned study models	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of anchorage loss	Evaluation and comparison of the amount of maxillary molar mesial movement (anchorage loss) between both groups via study models assessment.	6 Months

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: Abdullah M Al-Haj, MSc student, Al-Azhar University; Study Director: Farouk A Hussein, Ass.Prof, Al-Azhar University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2016
• Primary Completion (ACTUAL): June 10, 2018
• Study Completion (ACTUAL): February 24, 2019

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (ACTUAL): May 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Low Level Laser Therapy; Orthodontic Tooth movement; Canine Retraction; Two Protocols and Energy Doses
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: Laser Effect Canine Movement

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No