Laser Therapy on Orthodontic Tooth Movement

• Sponsor: Ildeu Andrade Jr. (Other)
• Overall Status: Completed
• CT.gov ID: NCT04070170
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 5
• Actual Duration (Months): 67.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The aims of this study will be to evaluate if a Lower Level Laser Therapy (LLLT): (1) enhances the levels of important pro-inflammatory chemokines involved in the bone remodeling process; (2) increases the rate of orthodontic tooth movement (OTM) on human subjects.

Condition or Disease	Intervention/Treatment	Phase
Laser Therapy; Orthodontic Tooth Movement; Bone Remodeling	Device: Low-level Laser Therapy; Procedure: Orthodontic force	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effects of Lower Level Laser Therapy on Orthodontic Tooth Movement
• Actual Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Nov 6, 2018
• Actual Study Completion Date: Sep 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low-level laser therapy and no orthodontic force No orthodontic force. Laser is applied on the first day and the premolars is extracted after 24 hours	Device: Low-level Laser Therapy; Low-level laser therapy is applied on premolars that will be extracted for treatment plan reasons
Experimental: Low-level laser therapy and application of orthodontic force Orthodontic force and Laser is applied on the first day and the premolars is extracted after 24 hours	Device: Low-level Laser Therapy; Low-level laser therapy is applied on premolars that will be extracted for treatment plan reasons; Procedure: Orthodontic force; Mechanical loading is applied on premolars that will be extracted for treatment plan reasons and in canines for tooth movement
Active Comparator: Orthodontic force only Orthodontic force is applied and the premolars is extracted after 24 hours, with no laser therapy	Procedure: Orthodontic force; Mechanical loading is applied on premolars that will be extracted for treatment plan reasons and in canines for tooth movement
Experimental: Low-level laser therapy and orthodontic force Orthodontic force and Laser is applied and the orthodontic tooth movement is evaluated	Device: Low-level Laser Therapy; Low-level laser therapy is applied on premolars that will be extracted for treatment plan reasons; Procedure: Orthodontic force; Mechanical loading is applied on premolars that will be extracted for treatment plan reasons and in canines for tooth movement
Active Comparator: Orthodontic force with no laser therapy Orthodontic force is applied and the orthodontic tooth movement is evaluated, with no laser therapy	Procedure: Orthodontic force; Mechanical loading is applied on premolars that will be extracted for treatment plan reasons and in canines for tooth movement

Outcome Measures

Primary Outcome Measures

1. Rate of orthodontic tooth movement, with and without low-level laser therapy [The quantification of OTM was performed before canine retraction]

   The canine retraction was measured with a digital dynamometer

2. Rate of orthodontic tooth movement, with and without low-level laser therapy [The quantification of OTM was performed after 1 month of canine retraction]

   The canine retraction was measured with a digital dynamometer

3. Rate of orthodontic tooth movement, with and without low-level laser therapy [The quantification of OTM was performed after 2 months of canine retraction]

   The canine retraction was measured with a digital dynamometer

4. Rate of orthodontic tooth movement, with and without low-level laser therapy [The quantification of OTM was performed after 3 months of canine retraction]

   The canine retraction was measured with a digital dynamometer

Secondary Outcome Measures

1. Chemokine levels in the periodontal tissue after LLLT and orthodontic force [The chemokine levels were assayed on days 0, 1, 7 and 14 after application of orthodontic force and low-level laser therapy]

   The chemokine levels were measured in the periodontal tissue after LLLT and orthodontic force by means of a cytometric bead array (CBA)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Facial convexity

• Protrusion or biprotrusion of the incisors

• Dental crowding

• Healthy periodontal condition

• Satisfactory oral hygiene

Exclusion Criteria:

• Patients under medications that may interfere with bone metabolism, such as anti-inflammatory, antibiotics and hormonal supplements in the previous three months

• Skeletal crossbite

• Parafunctional habits

• Occlusal interference

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pontifical Catholic University of Minas Gerais	Belo Horizonte	MG	Brazil	30535-901

Sponsors and Collaborators

• Ildeu Andrade Jr.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Alhashimi N, Frithiof L, Brudvik P, Bakhiet M. Chemokines are upregulated during orthodontic tooth movement. J Interferon Cytokine Res. 1999 Sep;19(9):1047-52.
• Doshi-Mehta G, Bhad-Patil WA. Efficacy of low-intensity laser therapy in reducing treatment time and orthodontic pain: a clinical investigation. Am J Orthod Dentofacial Orthop. 2012 Mar;141(3):289-297. doi: 10.1016/j.ajodo.2011.09.009.
• Genc G, Kocadereli I, Tasar F, Kilinc K, El S, Sarkarati B. Effect of low-level laser therapy (LLLT) on orthodontic tooth movement. Lasers Med Sci. 2013 Jan;28(1):41-7. doi: 10.1007/s10103-012-1059-6. Epub 2012 Feb 18.
• Kim SJ, Moon SU, Kang SG, Park YG. Effects of low-level laser therapy after Corticision on tooth movement and paradental remodeling. Lasers Surg Med. 2009 Sep;41(7):524-33. doi: 10.1002/lsm.20792.
• Torri S, Weber JB. Influence of low-level laser therapy on the rate of orthodontic movement: a literature review. Photomed Laser Surg. 2013 Sep;31(9):411-21. doi: 10.1089/pho.2013.3497. Epub 2013 Jul 24. Review.

• Responsible Party: Ildeu Andrade Jr., Professor, Pontifícia Universidade Católica de Minas Gerais
• ClinicalTrials.gov Identifier: NCT04070170
• Other Study ID Numbers: Laser on tooth movement
• First Posted: Aug 28, 2019
• Last Update Posted: Sep 24, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Ildeu Andrade Jr., Professor, Pontifícia Universidade Católica de Minas Gerais: Low-Level Light Therapy; Tooth Movement; Bone Remodeling

Study Results

No Results Posted as of Sep 24, 2020