Los Efectos del Suplemento de Magnesio (Mg) y la Expansión y Constricción Maxilar Alterna (Alt-RAMEC) en Pacientes con Deficiencia Maxilar Transversal (TMD) (Mg + Alt-RAMEC)
13 de septiembre de 2026 actualizado por: IBRAHEEM RAHMA HAZIM IBRAHEEM, Universiti Sains Malaysia
Los Efectos del Suplemento de Magnesio (Mg) y la Expansión y Constricción Maxilar Alternada (Alt-RAMEC) en Pacientes con Deficiencia Maxilar Transversal (TMD): Un Ensayo Clínico Aleatorizado.
Este ensayo clínico aleatorizado evalúa el efecto de combinar la suplementación con magnesio con una técnica ortodóncica llamada Expansión y Constricción Maxilar Alterna (Alt-RAMEC) utilizando un dispositivo de Expansión Palatina Rápida Asistida por Microimplantes (MARPE) para tratar a adultos (18-30 años) con deficiencia maxilar transversal (DMT). La DMT es una condición en la que la mandíbula superior es más estrecha de lo normal, lo que puede afectar la mordida y el desarrollo facial.
El estudio involucra dos grupos: uno recibe el protocolo Alt-RAMEC con MARPE solo, y el otro recibe el mismo protocolo junto con suplementos orales de magnesio. La efectividad de estos tratamientos se comparará evaluando los cambios en las estructuras dentales y esqueléticas mediante técnicas de imagen y evaluando la función muscular. Los participantes también informarán sus niveles de dolor y malestar durante el tratamiento.
Esta investigación tiene como objetivo comprender si la suplementación con magnesio puede potenciar los efectos del tratamiento Alt-RAMEC, mejorar los resultados de los pacientes y reducir las molestias asociadas con los procedimientos ortodóncicos.
Descripción general del estudio
Estado
Estado
Terminado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Este ensayo clínico tiene como objetivo evaluar la efectividad de la suplementación con magnesio combinada con el protocolo de Expansión y Constricción Maxilar Alternada (Alt-RAMEC) utilizando Expansión Palatina Rápida Asistida por Microimplantes (MARPE) en pacientes adultos con deficiencia maxilar transversal (DMT). El estudio compara dos grupos de tratamiento: uno que recibe el protocolo Alt-RAMEC con MARPE únicamente, y otro que recibe Alt-RAMEC con MARPE junto con suplementación oral de magnesio.
El protocolo Alt-RAMEC implica ciclos controlados de expansión y constricción maxilar para facilitar la corrección de discrepancias transversales maxilares. Los pacientes son tratados con regímenes específicos de activación y desactivación que involucran el aparato MARPE durante varias semanas. Este estudio evalúa los cambios en las estructuras dentales, alveolares, esqueléticas y musculares mediante el uso de imágenes avanzadas como la Tomografía Computarizada de Haz Cónico 3D (CBCT) y la electromiografía de superficie (sEMG). Además, se evaluarán los niveles de dolor y malestar reportados por los pacientes durante el tratamiento ortodóntico.
Este ensayo se centra en medir objetivamente los cambios morfológicos y funcionales para determinar si la ingesta de magnesio mejora los efectos del tratamiento Alt-RAMEC y aumenta la comodidad del paciente y los resultados del tratamiento. Los hallazgos pueden proporcionar evidencia valiosa para optimizar los protocolos de manejo de la deficiencia maxilar transversal en pacientes adultos jóvenes.
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
Inscripción
38
Fase
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
Estudio Contacto
- Nombre: Rahma Hazim Al-Hussainy, MSc
- Número de teléfono: 00964773245212 +9647732452128
- Correo electrónico: rahma_haz111@student.usm.my
Ubicaciones de estudio
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Al-Batawen
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Baghdad, Al-Batawen, Irak, 10001
- Dr. Aws Fakhri Alfatlawi specialized Orthodontics Clinic
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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
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
Criterios de inclusión
- Todos los participantes eran adultos jóvenes, del grupo de edad de 18 a 25 años (hombres o mujeres).
- Existe una deficiencia esquelética maxilar en cada paciente. (Deficiencia anteroposterior, deficiencia transversal bilateral/unilateral)
- Todos los dientes han erupcionado sin anomalías en cuanto a forma y tamaño.
- Buena higiene oral y hábitos de no fumar.
Criterios de exclusión:
- Antecedentes de tratamiento ortodóncico previo o expansión maxilar
- Pacientes con enfermedad periodontal progresiva grave
- Pacientes con deformidades craneomaxilofaciales graves como labio leporino y paladar hendido
- Fusión palatina media sin expansión exitosa
- Ausencia o inclusión del primer molar en el paciente.
- Pacientes que presentan pérdida ósea, recesión gingival o inflamación gingival persistente.
- Individuos con reflejo nauseoso alto.
- Antecedentes de una afección médica potencialmente mortal, como diabetes mellitus, o una enfermedad crónica como rechazo de trasplante de órganos o cáncer en pacientes que reciben quimioterapia o radioterapia y alto riesgo de infecciones.
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
Número de brazos
2
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Comparador activo: Alt-RAMEC/MARPE Without Magnesium Supplementation
Participants receive alternate rapid maxillary expansion and constriction (Alt-RAMEC) using a micro-implant-assisted rapid palatal expansion (MARPE) appliance without magnesium supplementation.
The appliance consists of a 10-mm Maxillary Skeletal Expander II supported by four palatal miniscrews.
Activation consists of two expansion quarter-turns daily in weeks 1 and 3, one reverse quarter-turn daily in weeks 2 and 4, and one to two expansion quarter-turns daily in week 5 until the clinical expansion endpoint is reached.
Weeks 6-12 comprise passive retention and follow-up.
The appliance and activation schedule are identical to those used in the experimental arm; this arm serves as the control for evaluating the additional effects of magnesium supplementation.
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Participants receive alternate rapid maxillary expansion and constriction (Alt-RAMEC) using a micro-implant-assisted rapid palatal expansion (MARPE) appliance.
The appliance consists of a 10-mm Maxillary Skeletal Expander II supported by four palatal miniscrews, each 1.8 mm in diameter and 11 mm in length.
Activation consists of two expansion quarter-turns daily in weeks 1 and 3, one reverse quarter-turn daily in weeks 2 and 4, and one to two expansion quarter-turns daily in week 5 until the clinical expansion endpoint is reached.
Weeks 6-12 comprise passive retention and follow-up.
The same appliance and activation protocol are used in both study arms.
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Experimental: Alt-RAMEC/MARPE With Magnesium Citrate Supplementation
Participants receive alternate rapid maxillary expansion and constriction (Alt-RAMEC) using a micro-implant-assisted rapid palatal expansion (MARPE) appliance, together with oral magnesium citrate providing 400 mg of elemental magnesium daily, administered as three capsules with food for 12 weeks from the first day of activation.
The appliance consists of a 10-mm Maxillary Skeletal Expander II supported by four palatal miniscrews.
Activation consists of two expansion quarter-turns daily in weeks 1 and 3, one reverse quarter-turn daily in weeks 2 and 4, and one to two expansion quarter-turns daily in week 5 until the clinical expansion endpoint is reached.
Weeks 6-12 comprise passive retention and follow-up, while magnesium supplementation continues.
|
Participants receive alternate rapid maxillary expansion and constriction (Alt-RAMEC) using a micro-implant-assisted rapid palatal expansion (MARPE) appliance.
The appliance consists of a 10-mm Maxillary Skeletal Expander II supported by four palatal miniscrews, each 1.8 mm in diameter and 11 mm in length.
Activation consists of two expansion quarter-turns daily in weeks 1 and 3, one reverse quarter-turn daily in weeks 2 and 4, and one to two expansion quarter-turns daily in week 5 until the clinical expansion endpoint is reached.
Weeks 6-12 comprise passive retention and follow-up.
The same appliance and activation protocol are used in both study arms.
Participants in the experimental arm receive oral magnesium citrate providing a total of 400 mg of elemental magnesium per day, administered as three capsules once daily with food for 12 weeks from the first day of MARPE activation.
Supplementation continues during both the active Alt-RAMEC treatment period and the subsequent passive retention period.
Participants in the active comparator arm receive no magnesium supplementation or placebo.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in Anterior Midpalatal Suture Separation at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in anterior midpalatal suture separation measured in millimetres (mm) using cone-beam computed tomography (CBCT) at the anterior nasal spine (ANS) level.
Measurements are assessed before the first activation of micro-implant-assisted rapid palatal expansion (MARPE; T0) and 12 weeks after activation begins (T1).
The change is calculated as the T1 measurement minus the T0 measurement.
Positive values indicate increased separation at the anterior part of the midpalatal suture.
Changes are compared between participants receiving the alternate maxillary expansion and constriction (Alt-RAMEC) protocol with magnesium supplementation and those receiving the same protocol without magnesium supplementation.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in Posterior Midpalatal Suture Separation at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in posterior midpalatal suture separation measured in millimetres (mm) using cone-beam computed tomography (CBCT) at the posterior nasal spine (PNS) level.
Measurements are assessed before the first activation of micro-implant-assisted rapid palatal expansion (MARPE; T0) and 12 weeks after activation begins (T1).
The change is calculated as the T1 measurement minus the T0 measurement.
Positive values indicate increased separation at the posterior part of the midpalatal suture.
Changes are compared between participants receiving the alternate maxillary expansion and constriction (Alt-RAMEC) protocol with magnesium supplementation and those receiving the same protocol without magnesium supplementation.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Otras medidas de resultado
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in Interzygomatic Width at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in interzygomatic width measured in millimetres using cone-beam computed tomography (CBCT).
Interzygomatic width is the distance between the anterior outer points of the right and left zygomaticomaxillary sutures on a standardized axial section.
Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0).
Positive values indicate increased transverse width.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Maxillary Jugale-to-Jugale Width at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in the transverse distance between the right and left jugale landmarks, measured in millimetres using cone-beam computed tomography (CBCT).
Each jugale landmark is identified at the intersection of the outlines of the maxillary tuberosity and zygomatic process on a standardized coronal section.
Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0).
Positive values indicate increased maxillary width.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Relative Palatal Expansion Ratio at 12 Weeks
Periodo de tiempo: 12 weeks after the first MARPE activation (T1).
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The proportion of mechanical expansion expressed as skeletal midpalatal suture opening.
The mean change in suture separation at the anterior nasal spine (ANS) and posterior nasal spine (PNS), measured using cone-beam computed tomography, is divided by the recorded mechanical expansion of the MARPE screw in millimetres.
The calculation is [(ANS change + PNS change)/2]/mechanical expansion.
The outcome is reported as a unitless ratio (mm/mm).
Higher values indicate greater skeletal opening per unit of mechanical expansion.
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12 weeks after the first MARPE activation (T1).
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Change from Baseline in Maxillary Alveolar Width at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in maxillary alveolar width measured in millimetres using cone-beam computed tomography (CBCT).
Alveolar width is measured between the right and left buccal alveolar bone surfaces on a standardized coronal section along the line connecting the maxillary first-molar furcations.
Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0).
Positive values indicate increased alveolar width.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Maxillary First-Molar Interfurcation Width at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in the distance between the furcations of the right and left maxillary first molars, measured in millimetres using cone-beam computed tomography (CBCT).
Measurements are obtained on standardized coronal sections showing both furcations.
Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0).
Positive values indicate increased interfurcation width.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Right Maxillary First-Molar Inclination at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in the inclination of the right maxillary first molar, measured in degrees using cone-beam computed tomography (CBCT).
Inclination is the angle between the palatal reference line and the palatal root axis, defined by the root apex and canal orifice, on a standardized coronal section.
Change is calculated as the angle at 12 weeks (T1) minus the baseline angle (T0).
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Left Maxillary First-Molar Inclination at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in the inclination of the left maxillary first molar, measured in degrees using cone-beam computed tomography (CBCT).
Inclination is the angle between the palatal reference line and the palatal root axis, defined by the root apex and canal orifice, on a standardized coronal section.
Change is calculated as the angle at 12 weeks (T1) minus the baseline angle (T0)
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Right Maxillary Alveolar Inclination at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in right maxillary alveolar inclination, measured in degrees using cone-beam computed tomography (CBCT).
Alveolar inclination is the angle between the right palatal alveolar bone and the palatal plane on a standardized coronal section.
Change is calculated as the angle at 12 weeks (T1) minus the baseline angle (T0).
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Buccal Bone Thickness at the Right Maxillary First Molar at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in buccal bone thickness at the right maxillary first molar, measured in millimetres using cone-beam computed tomography (CBCT).
Thickness is measured from the root surface to the outer buccal bone surface at the first-molar trifurcation level on a standardized coronal section.
Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0).
Negative values indicate reduced buccal bone thickness.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Buccal Bone Thickness at the Left Maxillary First Molar at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in buccal bone thickness at the left maxillary first molar, measured in millimetres using cone-beam computed tomography (CBCT).
Thickness is measured from the root surface to the outer buccal bone surface at the first-molar trifurcation level on a standardized coronal section.
Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0).
Negative values indicate reduced buccal bone thickness.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Mean Midpalatal CBCT Gray Value at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in the mean cone-beam computed tomography (CBCT) gray value within a standardized 4-mm-diameter region of interest centered on the midpalatal suture at the level of the line connecting the palatal roots of the maxillary first molars.
Corresponding regions are assessed at baseline and 12 weeks using standardized image orientation.
Change is calculated as the mean gray value at T1 minus the mean gray value at T0 and is reported in CBCT gray-value units.
This measurement is a relative radiographic density proxy, not calibrated bone mineral density.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Maxillary Intercanine Width at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in maxillary intercanine width measured in millimetres on digital dental models obtained by intraoral scanning.
Intercanine width is the distance between the cusp tips of the right and left maxillary canines.
Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0).
Positive values indicate increased intercanine width.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Maxillary Intermolar Width at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in maxillary intermolar width measured in millimetres on digital dental models obtained by intraoral scanning.
Intermolar width is the distance between the mesiobuccal cusp tips of the right and left maxillary first molars.
Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0).
Positive values indicate increased intermolar width.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Maxillary Anterior Arch Length at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in maxillary anterior arch length measured in millimetres on digital dental models.
Anterior arch length is the perpendicular distance from the line joining the right and left maxillary canine cusp tips to the most prominent maxillary central-incisor point.
Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0).
Positive values indicate increased anterior arch length.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Maxillary Molar-Level Arch Length at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in maxillary arch length at the first-molar level, measured in millimetres on digital dental models.
The measurement is the perpendicular distance from the line joining the mesiobuccal cusp tips of the right and left maxillary first molars to the most prominent maxillary central-incisor point.
Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0).
Positive values indicate increased arch length.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Palatal Width at the Maxillary Canine Level at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in palatal width at the maxillary canine level, measured in millimetres on digital dental models.
Width is measured between the right and left palatal gingival-margin midpoints at the maxillary canines.
Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0).
Positive values indicate increased palatal width at the canine level.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Palatal Width at the Maxillary First-Molar Level at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in palatal width at the maxillary first-molar level, measured in millimetres on digital dental models.
Width is measured between the right and left palatal gingival-margin points corresponding to the centers of the mesiopalatal cusps of the maxillary first molars.
Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0).
Positive values indicate increased palatal width at the first-molar level.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Normalized Right Masseter Activity During Chewing at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in normalized surface electromyographic activity of the right masseter muscle during a standardized chewing task.
At each assessment, the root mean square (RMS) amplitude during chewing is divided by the same muscle's RMS amplitude during maximum voluntary clenching in intercuspation, recorded during the same session, and multiplied by 100.
Change is calculated as the normalized value at 12 weeks (T1) minus the baseline value (T0) and is expressed in percentage points of maximum voluntary clench-normalized activity.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Normalized Left Masseter Activity During Chewing at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in normalized surface electromyographic activity of the left masseter muscle during a standardized chewing task.
At each assessment, the root mean square (RMS) amplitude during chewing is divided by the same muscle's RMS amplitude during maximum voluntary clenching in intercuspation, recorded during the same session, and multiplied by 100.
Change is calculated as the normalized value at 12 weeks (T1) minus the baseline value (T0) and is expressed in percentage points of maximum voluntary clench-normalized activity.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Normalized Right Anterior Temporalis Activity During Chewing at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in normalized surface electromyographic activity of the right anterior temporalis muscle during a standardized chewing task.
At each assessment, the root mean square (RMS) amplitude during chewing is divided by the same muscle's RMS amplitude during maximum voluntary clenching in intercuspation, recorded during the same session, and multiplied by 100.
Change is calculated as the normalized value at 12 weeks (T1) minus the baseline value (T0) and is expressed in percentage points of maximum voluntary clench-normalized activity.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Normalized Left Anterior Temporalis Activity During Chewing at 12 Weeks
Periodo de tiempo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change in normalized surface electromyographic activity of the left anterior temporalis muscle during a standardized chewing task.
At each assessment, the root mean square (RMS) amplitude during chewing is divided by the same muscle's RMS amplitude during maximum voluntary clenching in intercuspation, recorded during the same session, and multiplied by 100.
Change is calculated as the normalized value at 12 weeks (T1) minus the baseline value (T0) and is expressed in percentage points of maximum voluntary clench-normalized activity.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Overall Activation-Period Pain Intensity Assessed at 12 Weeks
Periodo de tiempo: Assessed 12 weeks after the first MARPE activation (T1), recalling pain during the active treatment period.
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Participant-reported overall pain intensity experienced during the active alternate maxillary expansion and constriction (Alt-RAMEC) treatment period, assessed at the 12-week visit using a 0-10 pain intensity scale.
A score of 0 indicates no pain or discomfort, and a score of 10 indicates the worst imaginable pain or discomfort.
Higher scores indicate greater pain intensity.
The outcome is reported in scale points and represents recalled overall activation-period pain, not a change from baseline.
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Assessed 12 weeks after the first MARPE activation (T1), recalling pain during the active treatment period.
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Number of Participants by Most Frequent Pain Location During Active Treatment
Periodo de tiempo: Assessed 12 weeks after the first MARPE activation (T1), recalling the most frequent pain location during the active treatment period.
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The most frequent location of pain experienced during the active alternate maxillary expansion and constriction (Alt-RAMEC) treatment period, reported using a structured questionnaire at the 12-week visit.
Participants select one location: anterior palate, posterior palate, molar region, or zygomatic region.
The outcome is reported as the number of participants selecting each location.
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Assessed 12 weeks after the first MARPE activation (T1), recalling the most frequent pain location during the active treatment period.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
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)
Inicio del estudio
21 de enero de 2025
Finalización primaria (Actual)
Finalización primaria
31 de diciembre de 2025
Finalización del estudio (Actual)
Finalización del estudio
31 de diciembre de 2025
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
30 de noviembre de 2025
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
19 de diciembre de 2025
Publicado por primera vez (Actual)
Publicado por primera vez
30 de diciembre de 2025
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
16 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
13 de septiembre de 2026
Última verificación
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- USM/JEPeM/KK/24070610
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Los Datos de Participantes Individuales (IPD) no se compartirán fuera del equipo de investigación debido a preocupaciones relacionadas con la protección de la confidencialidad y privacidad de los pacientes.
Los datos contienen información de salud sensible, y compartirlos podría suponer riesgos a pesar de los esfuerzos de desidentificación.
Además, el intercambio de datos está sujeto a aprobaciones éticas y acuerdos que limitan la difusión para salvaguardar los derechos de los participantes.
Esta restricción garantiza el cumplimiento de los estándares institucionales, éticos y legales que rigen la seguridad de los datos de los participantes.
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
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