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Efficiency of Canine Retraction Using Different Reactivation Intervals

23 de mayo de 2021 actualizado por: Yehya Mostafa, Future University in Egypt

Comparing Canine Retraction Using Two-week, Four-week, Six-week and Eight-week Reactivation Intervals

Canine retraction after 1st premolar extracion into the extraction space is a routine treatment in orthodontics. Orthodontic patients requiring first premolar extraction, canine retraction and maximum anchorage were recruited for this randomized controlled trial. A search of the literature did not indicate the ideal frequency of elastomeric chain reactivation for optimum canine retraction. The study was approved by the ethical committee. The first premolars were extracted. Elastomeric chains were used to retract the canine distally into the 1st premolar space. The optimum reactivation interval was evaluated regarding the efficiency of treatment in terms of rate of canine retraction, canine tipping and rotation, root resorption and pain at the intervals of 2, 4, 6 and 8 weeks. Three dimensional imaging, as well as digital scanning were the methods for data collection.

Descripción general del estudio

Descripción detallada

The canines, 2nd premolars, 1st molars and 2nd molars were bonded and banded. Leveling and alignment was achieved. After the first premolar extraction, temporary anchorage devices were inserted interradicular between 2nd premolar and 1st molar. Canine retraction was performed on a 0.016" X 0.022" stainless steel arch wire. A power arm was extended to apply the force closer to the center of resistance and achieve bodily movement. Elastomeric chains were calibrated to deliver a force of 150g and extended from the power arm to the mini screws directly. Recruited patients were randomly allocated to four groups according to the duration between the elastomeric chain reactivation. Canine reactivation intervals were 2, 4, 6, or 8 weeks. Cone beam computed tomography was performed before canine retraction and after 6 months of retraction. Digital dental casts were taken before canine retraction and monthly for 6 months.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

56

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.

Estudio Contacto

  • Nombre: Reem ElShazly, MSc
  • Número de teléfono: +201114666516
  • Correo electrónico: reemhazem24@gmail.com

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

      • Cairo, Egipto, 11865
        • Reclutamiento
        • Future University in Egypt
        • Contacto:

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

13 años a 30 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients requiring 1st premolar extraction (e.g bimaxillary dentoalveolar protrusion)
  • Erupted full set of permanent teeth (excluding 3rd molars)

Exclusion Criteria:

  • Systemic diseases that would interfere with bone metabolism
  • Craniofacial syndromes
  • congenitally missing or extracted permanent teeth.
  • periodontally compromised patients
  • smokers
  • pregnant women
  • previous orthodontic treatment

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: 2-week reactivation interval
Replacement of elastomeric chain every 2 weeks and reestablishing a 150 g force
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.
Comparador activo: 4-week reactivation interval
Replacement of elastomeric chain every 4 weeks and reestablishing a 150 g force
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.
Experimental: 6-week reactivation interval
Replacement of elastomeric chain every 6 weeks and reestablishing a 150 g force
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.
Experimental: 8-week reactivation interval
Replacement of elastomeric chain every 8 weeks and reestablishing a 150 g force
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Rate of canine retraction
Periodo de tiempo: Baseline to 1 month
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
Baseline to 1 month
Rate of canine retraction
Periodo de tiempo: 1month to 2 months
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
1month to 2 months
Rate of canine retraction
Periodo de tiempo: 2 months to 3 months
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
2 months to 3 months
Rate of canine retraction
Periodo de tiempo: 3 months to 4 months
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
3 months to 4 months
Rate of canine retraction
Periodo de tiempo: 4 months to 5 months
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
4 months to 5 months
Rate of canine retraction
Periodo de tiempo: 5 months to 6 months.
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
5 months to 6 months.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Amount of canine retraction
Periodo de tiempo: Baseline to 6 months
The change in distance measured from the canine cusp tip to the frontal plane, in millimeters; measured on CBCT
Baseline to 6 months
Canine tipping
Periodo de tiempo: Baseline to 6 months
CBCT images at T0 and T1 were analyzed using Invivo 5 software. linear measurements were made from the long axis of the canines (cusp tip to root apex) to FP1 and FP2 for the upper and lower canines, respectively.
Baseline to 6 months
Canine rotation
Periodo de tiempo: Baseline to 6 months
The change in the angle between a line connecting the maximum mesial and distal crown convexities and FP1 and FP2, for the upper and lower canines, respectively; measured on CBCT
Baseline to 6 months
Canine root resorption
Periodo de tiempo: Baseline to 6 months
The change in the canine length, in millimeters, measured from cusp tip to root apex; measured on CBCT
Baseline to 6 months
First molar anchorage loss
Periodo de tiempo: Baseline to 6 months
The change in distance measured from the mesio-buccal cusp tip of the first molar to the frontal plane, in millimeters; measured on CBCT
Baseline to 6 months
Pain score
Periodo de tiempo: baseline to day 1
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
baseline to day 1
Pain score
Periodo de tiempo: Baseline to day 2
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Baseline to day 2
Pain score
Periodo de tiempo: Baseline to day 3
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Baseline to day 3
Pain score
Periodo de tiempo: Baseline to day 4
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Baseline to day 4
Pain score
Periodo de tiempo: Baseline to day 5
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Baseline to day 5
Pain score
Periodo de tiempo: Baseline to day 6
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Baseline to day 6
Pain score
Periodo de tiempo: Baseline to day 7
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Baseline to day 7
Pain score
Periodo de tiempo: Baseline to day 8
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Baseline to day 8
Pain score
Periodo de tiempo: Baseline to day 9
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Baseline to day 9
Pain score
Periodo de tiempo: Baseline to day 10.
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Baseline to day 10.

Colaboradores e Investigadores

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

Investigadores

  • Director de estudio: Yehya Mostafa, PhD, Future University in Egypt

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)

1 de abril de 2017

Finalización primaria (Anticipado)

1 de junio de 2022

Finalización del estudio (Anticipado)

1 de junio de 2022

Fechas de registro del estudio

Enviado por primera vez

23 de mayo de 2021

Primero enviado que cumplió con los criterios de control de calidad

23 de mayo de 2021

Publicado por primera vez (Actual)

27 de mayo de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de mayo de 2021

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

23 de mayo de 2021

Última verificación

1 de mayo de 2021

Más información

Términos relacionados con este estudio

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. .

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