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

NCT05120102 | Unknown

• 1 other identifier: DuhsDikiohs
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orthodontic Appliance Complication

Outcome Measures

Primary Outcomes (1)

• orthodontic tooth movement

  tooth movement measured in millimeters

  6months

Secondary Outcomes (1)

• orthodontic pain

  6months

Study Arms (2)

Experimental side of the arch

EXPERIMENTAL

The right or left side of the patients maxillary arch selected by randomization

Device: Diode laser

Placebo side of the arch

NO INTERVENTION

The right or left side of the patients maxillary arch selected by randomization

Interventions

Diode laser DEVICE

K2 diode laser of 980nm wavelength

Experimental side of the arch

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow university of health sciences

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Imtiaz Dr Ahmed, FCPS

  Supervisor

  STUDY DIRECTOR

Central Study Contacts

Hafiza M Khurshid, MDS

CONTACT

03432459580; mammarry21@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 15, 2021
• Study Start: August 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: August 30, 2023
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: For a year after completion
• Access Criteria: No such criteria

Locations

PA (1)