Influence of Low-level Laser Therapy on Stability and Displacement of Orthodontic Miniscrew Implants

January 17, 2018 updated by: Guido Artemio Marañón Vásquez, University of Sao Paulo

Effect of Low-level Laser Therapy on Stability and Displacement of Orthodontic Miniscrew Implants With Mediate and Immediate Force Application

The purpose of this study is to evaluate the effect of Low level laser therapy on stability and displacement of orthodontic miniscrew implants using two different force application protocols.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to evaluate the effect of Low level laser therapy (LLLT) on stability and displacement of orthodontic miniscrew implants with mediate and immediate force application. They will be assessed 48 miniscrew implants placed in patients in orthodontic treatment at the postgraduate clinical in Orthodontics, at School of Dentistry of Ribeirão Preto, University of São Paulo. They will be randomly divided into 4 groups: 1- LLLT and immediate force application; 2- LLLT and force application 4 weeks after implantation; 3- immediate force application without LLLT and 4- force application 4 weeks after implantation without LLLT. Orthodontic force of 150 gF will be applied for 3 months. A low power laser device Therapy XT with a wavelength of 660 nm and output of 100 mW immediately after implantation (energy density: 4J/cm2), and 808 nm with 100 mW (energy density: 8J/cm2), every 48 hours for two weeks in the following applications will be used. The stability will be assessed using Resonance Frequency Analysis (RFA) at three times: the implantation day (T1), one month (T2) and after 3 months of force application (T3). Stability measures will be evaluated in Implant Stability Quotient (ISQ). To assess the amount of miniscrew implant displacement, it will be used Cone Beam Computed Tomography (CBCT) at the beginning (CT1) and final of the application of orthodontic force (CT2). Three-dimensional models will be created in specific programs and superimpositions of CT1 and CT2 will be used to measure the distance in millimeters between inicial and final position. The evaluation will be carried out in three points: head of miniscrew implant (point C), thread (point R) and apex of miniscrew implant (point A). The results will be statistically analyzed according to nature of the data and the significance level to be adopted will be 5%.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

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

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with permanent teeth.
  • Use of miniscrews in orthodontic planning.
  • Miniscrews placed in the labial upper and lower posterior regions.
  • Patient who agree to participate (Informed consent)

Exclusion Criteria:

  • Patient with systemic disease.
  • Patient with periodontal disease and/or inadequate oral hygiene.
  • Use of drugs chronically.
  • Patients that consume alcohol or tobacco.
  • Use of fixed palatal or lingual orthodontic devices.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LLLT + immediate force
Use of Low-level laser therapy and not mediate orthodontic force application (150 gF the day of the implantation).
Procedure: Low-level laser therapy
  1. Immediate post-operative period (implantation day) Red emission (660 nm) Energy density: 4 J/cm2 Power: 0.1W Irradiation area: 0,5 cm2 One application, 10 seconds of non-contact irradiation (01 point at the area surrounding the miniscrew) at a distance of 15,5 mm.
  2. Mediate post-operative period (after implantation day) Infrared emission (808 nm) Energy density: 8 J/cm2 Power: 0.1W Irradiation area: 0,5 cm2 6 applications every 48 hours after the day of implantation, 20 seconds of non-contact irradiation (01 point on the area surrounding the miniscrew) at a distance of 15,5 mm.
Experimental: LLLT + mediate force
Use of Low-level laser therapy and mediate orthodontic force application (150 gF 4 weeks after the day of the implantation).
Procedure: Low-level laser therapy
  1. Immediate post-operative period (implantation day) Red emission (660 nm) Energy density: 4 J/cm2 Power: 0.1W Irradiation area: 0,5 cm2 One application, 10 seconds of non-contact irradiation (01 point at the area surrounding the miniscrew) at a distance of 15,5 mm.
  2. Mediate post-operative period (after implantation day) Infrared emission (808 nm) Energy density: 8 J/cm2 Power: 0.1W Irradiation area: 0,5 cm2 6 applications every 48 hours after the day of implantation, 20 seconds of non-contact irradiation (01 point on the area surrounding the miniscrew) at a distance of 15,5 mm.
Procedure: Mediate force application
Mediate force application protocol: orthodontic force application (150 gF) 4 weeks after the day of the implantation.
No Intervention: Immediate force application
Not mediate orthodontic force application (150 gF the day of the implantation), without use of Low-level laser therapy.
Experimental: Mediate force application
Mediate orthodontic force application (150 gF 4 weeks after the day of the implantation), without use of Low-level laser therapy.
Procedure: Mediate force application
Mediate force application protocol: orthodontic force application (150 gF) 4 weeks after the day of the implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline miniscrew implant stability at 1 and 3 months of force application.
Time Frame: T1: Implantation day; T2: after 1 month; and, T3: after 3 months of force application.
It will be used a Resonance frequency analysis (RFA) equipment. Stability measures will be evaluated using a unique unit of measure: Implant stability quotient (ISQ). All groups will be evaluated the day of the implantation (T1) and after 1 month (T2).The last stability measure (T3) will be done 3 months after the implantation day in the groups without mediate force application, and 4 months after the implantation day in the groups with mediate force application.
T1: Implantation day; T2: after 1 month; and, T3: after 3 months of force application.
Change from baseline miniscrew implant position at 3 months of force application.
Time Frame: CT1: Implantation day; and, CT2: 3 months of orthodontic force application.
It will be used Cone Beam Computed tomography (CBCT). Three-dimensional models will be created in specific programs and superimpositions of CT1 and CT2 will be used to measure the distance in millimeters between initial and final position.
CT1: Implantation day; and, CT2: 3 months of orthodontic force application.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Guido A Marañón Vásquez, DDS, University of Sao Paulo

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

March 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 17, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • USaoPaulo-1

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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