NCT04070170

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2019

Completed
Last Updated

September 24, 2020

Status Verified

September 1, 2020

Enrollment Period

4.8 years

First QC Date

August 15, 2019

Last Update Submit

September 16, 2020

Conditions

Keywords

Low-Level Light TherapyTooth MovementBone Remodeling

Outcome Measures

Primary Outcomes (4)

  • Rate of orthodontic tooth movement, with and without low-level laser therapy

    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

    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

    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

    The canine retraction was measured with a digital dynamometer

    The quantification of OTM was performed after 3 months of canine retraction

Secondary Outcomes (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

Study Arms (5)

Low-level laser therapy and no orthodontic force

EXPERIMENTAL

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 and application of orthodontic force

EXPERIMENTAL

Orthodontic force and Laser is applied on the first day and the premolars is extracted after 24 hours

Device: Low-level Laser TherapyProcedure: Orthodontic force

Orthodontic force only

ACTIVE COMPARATOR

Orthodontic force is applied and the premolars is extracted after 24 hours, with no laser therapy

Procedure: Orthodontic force

Low-level laser therapy and orthodontic force

EXPERIMENTAL

Orthodontic force and Laser is applied and the orthodontic tooth movement is evaluated

Device: Low-level Laser TherapyProcedure: Orthodontic force

Orthodontic force with no laser therapy

ACTIVE COMPARATOR

Orthodontic force is applied and the orthodontic tooth movement is evaluated, with no laser therapy

Procedure: Orthodontic force

Interventions

Low-level laser therapy is applied on premolars that will be extracted for treatment plan reasons

Low-level laser therapy and application of orthodontic forceLow-level laser therapy and no orthodontic forceLow-level laser therapy and orthodontic force

Mechanical loading is applied on premolars that will be extracted for treatment plan reasons and in canines for tooth movement

Low-level laser therapy and application of orthodontic forceLow-level laser therapy and orthodontic forceOrthodontic force onlyOrthodontic force with no laser therapy

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Facial convexity
  • Protrusion or biprotrusion of the incisors
  • Dental crowding
  • Healthy periodontal condition
  • Satisfactory oral hygiene

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontifical Catholic University of Minas Gerais

Belo Horizonte, Minas Gerais, 30535-901, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 22381489BACKGROUND
  • 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.

    PMID: 10505748BACKGROUND
  • 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.

    PMID: 23883115BACKGROUND
  • 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.

    PMID: 22350425BACKGROUND
  • 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.

    PMID: 19639625BACKGROUND

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 15, 2019

First Posted

August 28, 2019

Study Start

February 1, 2014

Primary Completion

November 6, 2018

Study Completion

September 16, 2019

Last Updated

September 24, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations