Os Efeitos do Suplemento de Magnésio (Mg) e da Expansão e Constrição Máximas Alternadas (Alt-RAMEC) em Pacientes com Deficiência Maxilar Transversal (DMT) (Mg + Alt-RAMEC)
13 de setembro de 2026 atualizado por: IBRAHEEM RAHMA HAZIM IBRAHEEM, Universiti Sains Malaysia
Os Efeitos do Suplemento de Magnésio (Mg) e da Expansão e Constrição Maxilar Alternada (Alt-RAMEC) em Pacientes com Deficiência Maxilar Transversal (DMT): Um Ensaio Clínico Randomizado.
Este ensaio clínico randomizado avalia o efeito da combinação da suplementação de magnésio com uma técnica ortodôntica chamada Expansão e Constrição Maxilar Alternada (Alt-RAMEC) utilizando um aparelho de Expansão Palatina Rápida Assistida por Microimplantes (MARPE) para tratar adultos (18-30 anos) com deficiência maxilar transversal (DMT). A DMT é uma condição em que a maxila superior é mais estreita do que o normal, o que pode afetar a oclusão e o desenvolvimento facial.
O estudo envolve dois grupos: um recebe o protocolo Alt-RAMEC com MARPE apenas, e o outro recebe o mesmo protocolo juntamente com suplementos orais de magnésio. A eficácia destes tratamentos será comparada avaliando as alterações nas estruturas dentárias e esqueléticas através de técnicas de imagem e avaliando a função muscular. Os participantes também reportarão os seus níveis de dor e desconforto durante o tratamento.
Esta investigação visa compreender se a suplementação de magnésio pode potenciar os efeitos do tratamento Alt-RAMEC, melhorar os resultados dos pacientes e reduzir o desconforto associado aos procedimentos ortodônticos.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
Este ensaio clínico visa avaliar a eficácia da suplementação de magnésio combinada com o protocolo de Expansão e Constrição Maxilar Alternada (Alt-RAMEC) usando Expansão Palatina Rápida Assistida por Micro-implantes (MARPE) em pacientes adultos com deficiência maxilar transversal (TMD). O estudo compara dois grupos de tratamento: um que recebe o protocolo Alt-RAMEC com MARPE apenas, e outro que recebe Alt-RAMEC com MARPE juntamente com suplementação oral de magnésio.
O protocolo Alt-RAMEC envolve ciclos controlados de expansão e constrição maxilares para facilitar a correção de discrepâncias transversais maxilares. Os pacientes são tratados com regimes específicos de ativação e desativação envolvendo o aparelho MARPE ao longo de várias semanas. Este estudo avalia mudanças nas estruturas dentárias, alveolares, esqueléticas e musculares utilizando imagiologia avançada, como Tomografia Computorizada de Feixe Cónico 3D (CBCT) e electromiografia de superfície (sEMG). Adicionalmente, os níveis de dor e desconforto reportados pelos pacientes serão avaliados durante o tratamento ortodôntico.
Este ensaio concentra-se na medição objetiva de mudanças morfológicas e funcionais para determinar se a ingestão de magnésio potencia os efeitos do tratamento Alt-RAMEC e melhora o conforto do paciente e os resultados do tratamento. As conclusões podem fornecer evidências valiosas para otimizar protocolos de gestão da deficiência maxilar transversal em pacientes adultos jovens.
Tipo de estudo
Intervencional
Inscrição (Real)
38
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Al-Batawen
-
Baghdad, Al-Batawen, Iraque, 10001
- Dr. Aws Fakhri Alfatlawi specialized Orthodontics Clinic
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
Critérios de Inclusão:
Critérios de Inclusão
- Todos os participantes eram jovens adultos, do grupo etário dos 18-25 anos (homens ou mulheres).
- Existe uma deficiência esquelética maxilar em todos os pacientes. (Deficiência anteroposterior, deficiência transversal bilateral/unilateral)
- Todos os dentes erupcionaram sem quaisquer anomalias em termos de forma e tamanho.
- Boa higiene oral e hábitos não tabágicos.
Critérios de Exclusão:
- Histórico de tratamento ortodôntico prévio ou expansão maxilar
- Pacientes com doença periodontal progressiva grave
- Pacientes com deformidades craniomaxilofaciais graves, como lábio leporino e fenda palatina
- Fusão palatina mediana sem expansão bem-sucedida
- Primeiro molar ausente ou impactado no paciente.
- Pacientes que apresentam perda óssea, recessão gengival ou inflamação gengival persistente.
- Indivíduos com reflexo de vómito elevado.
- Histórico de condição médica com risco de vida, como diabetes mellitus, ou doença crónica como rejeição de transplante de órgão ou cancro em pacientes a receber quimioterapia ou radioterapia e alto risco de infeções.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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.
|
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.
|
|
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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from Baseline in Anterior Midpalatal Suture Separation at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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.
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from Baseline in Posterior Midpalatal Suture Separation at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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.
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from Baseline in Interzygomatic Width at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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.
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Change from Baseline in Maxillary Jugale-to-Jugale Width at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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.
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Relative Palatal Expansion Ratio at 12 Weeks
Prazo: 12 weeks after the first MARPE activation (T1).
|
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.
|
12 weeks after the first MARPE activation (T1).
|
|
Change from Baseline in Maxillary Alveolar Width at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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.
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Change from Baseline in Maxillary First-Molar Interfurcation Width at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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.
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Change from Baseline in Right Maxillary First-Molar Inclination at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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).
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Change from Baseline in Left Maxillary First-Molar Inclination at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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)
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Change from Baseline in Right Maxillary Alveolar Inclination at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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).
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Change from Baseline in Buccal Bone Thickness at the Right Maxillary First Molar at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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.
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Change from Baseline in Buccal Bone Thickness at the Left Maxillary First Molar at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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.
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Change from Baseline in Mean Midpalatal CBCT Gray Value at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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.
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Change from Baseline in Maxillary Intercanine Width at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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.
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Change from Baseline in Maxillary Intermolar Width at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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.
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Change from Baseline in Maxillary Anterior Arch Length at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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.
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Change from Baseline in Maxillary Molar-Level Arch Length at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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.
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Change from Baseline in Palatal Width at the Maxillary Canine Level at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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.
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Change from Baseline in Palatal Width at the Maxillary First-Molar Level at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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.
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Change from Baseline in Normalized Right Masseter Activity During Chewing at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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.
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Change from Baseline in Normalized Left Masseter Activity During Chewing at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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.
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Change from Baseline in Normalized Right Anterior Temporalis Activity During Chewing at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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.
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Change from Baseline in Normalized Left Anterior Temporalis Activity During Chewing at 12 Weeks
Prazo: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
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.
|
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
|
|
Overall Activation-Period Pain Intensity Assessed at 12 Weeks
Prazo: Assessed 12 weeks after the first MARPE activation (T1), recalling pain during the active treatment period.
|
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.
|
Assessed 12 weeks after the first MARPE activation (T1), recalling pain during the active treatment period.
|
|
Number of Participants by Most Frequent Pain Location During Active Treatment
Prazo: Assessed 12 weeks after the first MARPE activation (T1), recalling the most frequent pain location during the active treatment period.
|
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.
|
Assessed 12 weeks after the first MARPE activation (T1), recalling the most frequent pain location during the active treatment period.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
21 de janeiro de 2025
Conclusão Primária (Real)
31 de dezembro de 2025
Conclusão do estudo (Real)
31 de dezembro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
30 de novembro de 2025
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de dezembro de 2025
Primeira postagem (Real)
30 de dezembro de 2025
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- USM/JEPeM/KK/24070610
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Os Dados Individuais dos Participantes (IPD) não serão partilhados fora da equipa de investigação devido a preocupações relacionadas com a proteção da confidencialidade e privacidade dos doentes.
Os dados contêm informações sensíveis de saúde, e a sua partilha pode representar riscos, apesar dos esforços de desidentificação.
Além disso, a partilha de dados está sujeita a aprovações éticas e acordos que limitam a disseminação para salvaguardar os direitos dos participantes.
Esta restrição garante a conformidade com as normas institucionais, éticas e legais que regem a segurança dos dados dos participantes.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .