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The Use of Corticotomy for Upper Incisors Retraction

27 de julio de 2018 actualizado por: Damascus University

Evaluation of Treatment Outcomes of Corticotomy-accelerated Upper Incisors' Retraction: A Randomized Controlled Trial

We aim to assess the treatment outcomes following upper incisors retraction accelerated by corticotomy procedure. So, we intend to randomize orthodontic patients with class II division I malocclusion into two groups: experimental group and control group. Both groups will start orthodontic treatment. Once a 0.019*0.025-inch stainless steel wire is fully engaged to the brackets, 1st premolars will be extracted. Canines will be retracted in the conventional manner. Then, the actual evaluation period starts when the upper incisors are retracted using two different methods.

Descripción general del estudio

Estado

Terminado

Descripción detallada

In the last three decades, the number of adult patients seeking short orthodontic treatment time has apparently increased as the conventional orthodontic treatment usually lasts for 20-24 months. Furthermore, orthodontic treatment is often associated with root resorption, bone degradation and caries development. Patients nowadays desire to end the orthodontic treatment as soon as possible due to phsycosocial reasons and to get the goals of the treatment without affecting their social life .

So many tooth movement accelerating methods have been proposed. However, the surgical approached are considered the most effective and promising methods in accelerating tooth movement. The current research aims to evaluate the efficacy of the a new proposed surgical method compared to the conventional method in upper incisors' retraction.

Tipo de estudio

Intervencionista

Inscripción (Actual)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Damascus, República Árabe Siria, DM20AM18
        • Department of Orthodontics, University of Damascus Dental School

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

15 años a 27 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Adult patients 15 to 27 years , with permanent dentition , without hypodontia .
  • Overjet less than 10 mm
  • Normal or increased growth pattern (Diagnosed by Y-axis angle)
  • Mild to moderate crowding (Less than 3 mm)
  • After canines retraction , at least 3 mm space should be available distal the lateral incisors
  • Midline deviation shouldn't be more than 3 mm

Exclusion Criteria:

  • Medically contraindicated patients to oral surgery .
  • Existence of general health issue that affect orthodontic teeth movement
  • Previous orthodontic treatment
  • Mixed dentition
  • Hypodontia (Except third molars)
  • Bad oral hygiene

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Corticotomy-assisted Retraction
Corticotomy-assisted retraction will be performed in order to help in accelerating upper incisors' retraction
Using a tunneling technique, the researcher will perform the intervention in the alveolar bone surrounding the upper incisors before retraction.
Sin intervención: Conventional Retraction
Conventional retraction will be used in this group of patients by sliding mechanisms

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Rate of retraction
Periodo de tiempo: This will be measured at the completion of the retraction procedure, and is expected to take 2 months in the experimental group and four months in the control group.
The distance that the incisors moved during retraction divided by the time required to retract the four upper incisors to their ideal positions.
This will be measured at the completion of the retraction procedure, and is expected to take 2 months in the experimental group and four months in the control group.
Time required for retraction
Periodo de tiempo: This will be measured at the completion of the retraction procedure, and is expected to be within 2 months in the accelerated group and 4 months in the control group.
The time required from the beginning of incisors' retraction till the the completion of this procedure.
This will be measured at the completion of the retraction procedure, and is expected to be within 2 months in the accelerated group and 4 months in the control group.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in the axial inclination of upper incisors
Periodo de tiempo: A radiograph will be taken at T1: one day before upper incisors' retraction and T2: one day after the completion of upper incisors' retraction. Completion of upper incisors' retraction is expected to be within 2 months in the accelerated group and 4 mo
the angle between the long axis of the upper incisor and a reference plane drawn on a later cephalometric radiograph teken at two assessment times.
A radiograph will be taken at T1: one day before upper incisors' retraction and T2: one day after the completion of upper incisors' retraction. Completion of upper incisors' retraction is expected to be within 2 months in the accelerated group and 4 mo
Anchorage loss
Periodo de tiempo: This will be measured one day following the completion of retraction of the upper four incisors using plaster study models and is expected to be within 2 months in the accelerated group and 4 months in the control group
the amount of anchorage loss (in mm), which is the distance from a perpendicular line to the midpalatal suture and extends between central fossa of both upper first molars to the third palatal rugae . These measurements are made on plaster study models.
This will be measured one day following the completion of retraction of the upper four incisors using plaster study models and is expected to be within 2 months in the accelerated group and 4 months in the control group
Root resorption
Periodo de tiempo: An panoramic image will be taken at T1: one day before the commencement of incisor retraction and T2: one day following the completion of retraction and is expected to be within 2 months in the accelerated group and 4 months in the control group
This variable is related to the amount of incisor root resorption after treatment in both groups. This is measured on a panoramic image. The amount of root resorption = the length of an incisor after retraction subtracted from the length of an incisor before retraction. Two radiogrpahs are needed.
An panoramic image will be taken at T1: one day before the commencement of incisor retraction and T2: one day following the completion of retraction and is expected to be within 2 months in the accelerated group and 4 months in the control group

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Ghaith Al Imam, DDS, MSc student in Orthodontics, University of Damascus Dental School, Damascus, Syria

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 (Actual)

20 de agosto de 2016

Finalización primaria (Actual)

20 de enero de 2018

Finalización del estudio (Actual)

15 de abril de 2018

Fechas de registro del estudio

Enviado por primera vez

9 de mayo de 2017

Primero enviado que cumplió con los criterios de control de calidad

9 de mayo de 2017

Publicado por primera vez (Actual)

11 de mayo de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de julio de 2018

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

27 de julio de 2018

Última verificación

1 de julio de 2018

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • UDDS-Ortho-02-2017

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

Ensayos clínicos sobre Maloclusión Clase II División 1

Ensayos clínicos sobre Corticotomy-assisted Retraction

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