- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04070170
Laser Therapy on Orthodontic Tooth Movement
September 16, 2020 updated by: Ildeu Andrade Jr.
The Effects of Lower Level Laser Therapy on Orthodontic Tooth Movement
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
MG
-
Belo Horizonte, MG, Brazil, 30535-901
- Pontifical Catholic University of Minas Gerais
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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
|
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
|
Low-level laser therapy is applied on premolars that will be extracted for treatment plan reasons
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
|
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
|
Low-level laser therapy is applied on premolars that will be extracted for treatment plan reasons
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
|
Mechanical loading is applied on premolars that will be extracted for treatment plan reasons and in canines for tooth movement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of orthodontic tooth movement, with and without low-level laser therapy
Time Frame: The quantification of OTM was performed before canine retraction
|
The canine retraction was measured with a digital dynamometer
|
The quantification of OTM was performed before canine retraction
|
|
Rate of orthodontic tooth movement, with and without low-level laser therapy
Time Frame: The quantification of OTM was performed after 1 month of canine retraction
|
The canine retraction was measured with a digital dynamometer
|
The quantification of OTM was performed after 1 month of canine retraction
|
|
Rate of orthodontic tooth movement, with and without low-level laser therapy
Time Frame: The quantification of OTM was performed after 2 months of canine retraction
|
The canine retraction was measured with a digital dynamometer
|
The quantification of OTM was performed after 2 months of canine retraction
|
|
Rate of orthodontic tooth movement, with and without low-level laser therapy
Time Frame: The quantification of OTM was performed after 3 months of canine retraction
|
The canine retraction was measured with a digital dynamometer
|
The quantification of OTM was performed after 3 months of canine retraction
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chemokine levels in the periodontal tissue after LLLT and orthodontic force
Time Frame: 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)
|
The chemokine levels were assayed on days 0, 1, 7 and 14 after application of orthodontic force and low-level laser therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. doi: 10.1089/107999099313271.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2014
Primary Completion (Actual)
November 6, 2018
Study Completion (Actual)
September 16, 2019
Study Registration Dates
First Submitted
August 15, 2019
First Submitted That Met QC Criteria
August 24, 2019
First Posted (Actual)
August 28, 2019
Study Record Updates
Last Update Posted (Actual)
September 24, 2020
Last Update Submitted That Met QC Criteria
September 16, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- Laser on tooth movement
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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