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

17 de enero de 2018 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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%.

Tipo de estudio

Intervencionista

Inscripción (Actual)

29

Fase

  • No aplica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

11 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: LLLT + immediate force
Use of Low-level laser therapy and not mediate orthodontic force application (150 gF the day of the implantation).
  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).
  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.
Mediate force application protocol: orthodontic force application (150 gF) 4 weeks after the day of the implantation.
Sin intervención: 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.
Mediate force application protocol: orthodontic force application (150 gF) 4 weeks after the day of the implantation.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline miniscrew implant stability at 1 and 3 months of force application.
Periodo de tiempo: 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.
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Guido A Marañón Vásquez, DDS, University of Sao Paulo

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 2016

Finalización primaria (Actual)

1 de febrero de 2017

Finalización del estudio (Actual)

1 de agosto de 2017

Fechas de registro del estudio

Enviado por primera vez

23 de agosto de 2016

Primero enviado que cumplió con los criterios de control de calidad

31 de agosto de 2016

Publicado por primera vez (Estimar)

7 de septiembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de enero de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

17 de enero de 2018

Última verificación

1 de enero de 2018

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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