Posterior Resin Bite Turbos Effect on Maxillary Expansion Using a HYRAX Expander in Early Adolescents (HYRAX_ RME_SME)
Effect of Posterior Disarticulatory Resin Bite Turbos on the Rate of Maxillary Expansion Using HYRAX Expander in Early Adolescent Patients: Randomized Controlled Clinical Trial
Descripción general del estudio
Estado
Descripción detallada
This study is conducted as part of a Master's thesis in Orthodontics and aims to investigate the influence of posterior disarticulatory resin bite turbos on the rate of maxillary expansion achieved using a HYRAX expander in early adolescent patients.
The study evaluates whether modifying occlusal contacts can affect skeletal and dental responses during rapid maxillary expansion.
Participants will be monitored clinically throughout the expansion phase.
Participants will be assigned in two groups:
group 1: with posterior bite turbos group 2: without posterior bite turbos
Digital intraoral scans will be taken on a weekly basis to assess changes in maxillary dimensions and to accurately measure the rate and pattern of expansion over time.
These serial digital records provide high-resolution, non-invasive documentation of treatment progress.
CBCT will be taken before the expansion and after retention phase for skeletal and dental measurement .
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Donia Alashker
- Número de teléfono: 00201557372170
- Correo electrónico: donyaalashker7@mans.edu.eg
Ubicaciones de estudio
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Al Mansurah, Egipto
- Reclutamiento
- Orthodontic Department - Faculty of Dentistry Mansoura University
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Contacto:
- Faculty of Dentistry Mansoura University
- Número de teléfono: 0020502267151
- Correo electrónico: dentfac@mansoura.edu.eg
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients aged 10-14 years.
- Bilateral posterior cross bite.
- Functional lateral cross bite.
- Good general and oral health.
- Normal to decreased vertical height )average FMA 29.7 °± 4.2 °).23
Exclusion Criteria:
- Patients with cleft lip and palate.
- Severe facial asymmetry.
- Anterior open bite.
- Systemic conditions affecting tooth movement (e.g., diabetes, bone disorders).
- Previous orthodontic treatment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: group 1: HYRAX with posterior bite turbos
Participants in this arm receive a HYRAX rapid maxillary expansion appliance combined with posterior disarticulatory resin bite turbos.
The bite turbos are placed on posterior teeth to achieve occlusal disclusion, aiming to minimize occlusal interference during expansion and potentially enhance skeletal response.
The HYRAX expander is activated according to a standardized protocol throughout the treatment period, with regular follow-up using clinical assessment and weekly intraoral scans.
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Description: Arm 1: Participants in this group receive a HYRAX rapid maxillary expansion appliance combined with posterior disarticulatory resin bite turbos. The bite turbos are placed on the posterior teeth to disclude the occlusion, aiming to reduce occlusal interference and potentially enhance skeletal response during maxillary expansion. The HYRAX appliance is activated according to a standardized expansion protocol. |
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Comparador activo: Group 2 : Expansion without posterior bite turbos
Participants in this arm receive a HYRAX rapid maxillary expansion appliance without the use of posterior disarticulatory resin bite turbos.
The appliance is activated according to a standardized expansion protocol similar to the experimental group.
Patients are followed throughout the treatment period with regular clinical assessments and weekly intraoral scans to monitor changes in maxillary dimensions.
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Participants in this group receive a HYRAX rapid maxillary expansion appliance alone without the use of posterior bite turbos.
The appliance is activated following the same standardized expansion protocol as the intervention group.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The effect of occlusal disarticulation on the rate of maxillary expansion by linear measurements made on digital models
Periodo de tiempo: Baseline and weekly during the active phase of expansion and after 3 months of retention
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Dental landmarks and measurements on models : d3 :Canine tip. d4: Central fissure of first premolar. d6 :Central fissure of first permanent molar. d_3( inter canine width): Distance between left and right d3. d_4 (inter first premolar width) : Distance between left and right d4. d_6(inter first molar width): Distance between left and right d6. |
Baseline and weekly during the active phase of expansion and after 3 months of retention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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-The effect of the posterior disarticulation on alveolar bone changes by CBCT .
Periodo de tiempo: baseline and after three months of retention after complete active expansion
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Skeletal transverse, vertical, nasal width changes and axial inclination of posterior teeth will be evaluated .
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baseline and after three months of retention after complete active expansion
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pain felt by the patient after activating the expansion screw
Periodo de tiempo: first two weeks in active phase of expansion
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ain will be assessed using the Visual Analogue Scale (VAS), a 100 mm line with "no pain" at the left end and "the worst unbearable pain" at the right, which corresponds to a pain score between 0 and 10.
All participants will be asked to place a vertical mark indicating the level of pain on the VAS 4 h after each activation for the first two weeks in diary sheet containing the actual size of a 100mm of VAS. 25
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first two weeks in active phase of expansion
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Donia Alashker, Faculty of Dentistry Mansoura University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- MS.26.02.145
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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