Influence of Low Level Laser Therapy on the Rate of Orthodontic Tooth Movement and Associated Pain

This is a single blind randomized controlled trial with split mouth design including 45 patients with extractions of maxillary 1st bicuspids. First leveling and alignment will take place till 17 × 25 Stainless Steel wire pass passively through all the brackets. Canine retraction will be done through elastomeric ligatures maintaining force of 150gm on both sides. One of side of maxillary arch will be irradiated by diode laser (aluminum-gallium-arsenide) of 980nm on cervical, middle, and apical third on buccal and palatal surface of cuspid and the other side will act as placebo. Laser irradiation will be done at baseline and then for 3 more consecutive visits. Measurements will be recorded from maxillary canine hook to maxillary 1st molar hook at 3 weeks interval till complete canine retraction will be achieved. Patients will be given a questionnaires supported numeric scale to record their pain score for a week.

Study Overview

• Status: Recruiting
• Conditions: Orthodontic Appliance Complication
• Intervention / Treatment: Device: Diode laser

Detailed Description

First ethical approval for the study is going to be taken from the scientific committee and then Institutional Review Board of Dow University of Health Sciences. After getting informed consent from the chosen study participants, banding and bonding of the maxillary arch are going to be done through conventional fixed appliance Edgewise brackets. Initial leveling and alignment are going to be achieved by using nickel titanium and round stainless-steel wires until 0.017x0.025-inch stainless-steel wire passes passively through all fixed appliance. Anchorage is going to be implemented by skeletal anchorage through mini implants and molar stops on 0.017×0.025-inch stainless-steel wire just mesial to upper 1st molar band slot. As this study features a split mouth design so, every study subject will receive Gallium-Aluminum-Arsenic diode laser with a wavelength of 980nm ± 10nm on one maxillary canine and a placebo effect on the other maxillary canine. The side receiving laser irradiation is going to be alternated with every consecutive patient. To prevent from chauffeuring effect, a plastic shield will be used. The patient will be given questionnaire based scale to record pain score for a week.

Distalization of the canines is going to be accomplished by elastomeric chain (Medium span, Ortho Organizer) which can begin instantly after extraction of first premolars. There is no distinction between retraction rate of canines using either elastomeric chain or Nickel Titanium springs.

All study measurements will be taken using 0.01mm with digital Vernier caliper considering hook of maxillary cuspid teeth and hook of maxillary 1st molar teeth as reference points. Measurements will be recorded thrice in a single visit and mean is taken to avoid bias. Readings will be recorded after every three-weeks interval until one of the canines is completely retracted. Arch length will be measured on the cast as inter molar width. Patients will be given a questionnaire supported numeric scale to record their pain score for a week.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hafiza M Khurshid, MDS; Phone Number: 03432459580; Email: mammarry21@gmail.com

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Recruiting
      • Dow University of Health Sciences
      • Contact: Hafiza M Khurshid, MDS; Phone Number: 3432459580; Email: mammarry21@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age between 15-30 years
• Patients having symmetric extraction of maxillary 1st bicuspids
• All dentitions till 2nd molars should be erupted in the arch

Exclusion Criteria:

• Patients with Long term medication or with a history of radiotherapy or chemotherapy.
• Patients with Parafunctional habit.
• Patients with severe tooth displacement (ectopic canine), patients with missing teeth and impacted teeth (except third molars).
• Tooth morphological anomalies especially in the maxillary canines determined clinically or on OrthoPantomoGram/periapical X-rays.
• Patients with any systemic or metabolic disorder or bone pathology.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental side of the arch; The right or left side of the patients maxillary arch selected by randomization	Device: Diode laser; K2 diode laser of 980nm wavelength
No Intervention: Placebo side of the arch; The right or left side of the patients maxillary arch selected by randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
orthodontic tooth movement	tooth movement measured in millimeters	6months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
orthodontic pain	pain score through visual analogue scale having a score zero means no pain to score 5 means worst	6months

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences
• Investigators: Study Director: Imtiaz Dr Ahmed, FCPS, supervisor

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): August 30, 2023

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: November 4, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 14, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: DuhsDikiohs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Visit duhs web page
• IPD Sharing Time Frame: For a year after completion
• IPD Sharing Access Criteria: No such criteria
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

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