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

U

University of Sao Paulo

Status

Completed

Conditions

Mechanical Complication of Other Bone Devices, Implants and Grafts
Displacement of Other Bone Devices, Implants and Grafts

Treatments

Procedure: Mediate force application
Procedure: Low-level laser therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02891499
USaoPaulo-1

Details and patient eligibility

About

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.

Full 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%.

Enrollment

29 patients

Sex

All

Ages

11+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

29 participants in 4 patient groups

LLLT + immediate force
Experimental group
Description:
Use of Low-level laser therapy and not mediate orthodontic force application (150 gF the day of the implantation).
Treatment:
Procedure: Low-level laser therapy
LLLT + mediate force
Experimental group
Description:
Use of Low-level laser therapy and mediate orthodontic force application (150 gF 4 weeks after the day of the implantation).
Treatment:
Procedure: Low-level laser therapy
Procedure: Mediate force application
Immediate force application
No Intervention group
Description:
Not mediate orthodontic force application (150 gF the day of the implantation), without use of Low-level laser therapy.
Mediate force application
Experimental group
Description:
Mediate orthodontic force application (150 gF 4 weeks after the day of the implantation), without use of Low-level laser therapy.
Treatment:
Procedure: Mediate force application

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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