The Effects of Magnesium (Mg) Supplement and Alternate Maxillary Expansion and Constriction (Alt-RAMEC) in Patient With Transverse Maxillary Deficiency (TMD): A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- Change from Baseline in Anterior Midpalatal Suture Separation at 12 Weeks
研究概览
简要总结
This randomized clinical trial evaluates the effect of combining magnesium supplementation with an orthodontic technique called Alternate Maxillary Expansion and Constriction (Alt-RAMEC) using a Micro-implant Assisted Rapid Palatal Expansion (MARPE) appliance to treat adults (18-30 years) with transverse maxillary deficiency (TMD). TMD is a condition where the upper jaw is narrower than normal, which can affect bite and facial development.
The study involves two groups: one receiving the Alt-RAMEC protocol with MARPE alone, and the other receiving the same protocol alongside oral magnesium supplements. The effectiveness of these treatments will be compared by assessing changes in dental and skeletal structures through imaging techniques and evaluating muscle function. Participants will also report their pain and discomfort levels during the treatment.
This research aims to understand whether magnesium supplementation can enhance the effects of Alt-RAMEC treatment, improve patient outcomes, and reduce discomfort associated with orthodontic procedures.
详细描述
This clinical trial aims to evaluate the effectiveness of magnesium supplementation combined with the Alternate Maxillary Expansion and Constriction (Alt-RAMEC) protocol using Micro-implant Assisted Rapid Palatal Expansion (MARPE) in adult patients with transverse maxillary deficiency (TMD). The study compares two treatment groups: one receiving the Alt-RAMEC protocol with MARPE alone, and the other receiving Alt-RAMEC with MARPE alongside oral magnesium supplementation.
The Alt-RAMEC protocol involves controlled cycles of maxillary expansion and constriction to facilitate the correction of maxillary transverse discrepancies. Patients are treated with specific activation and deactivation regimens involving the MARPE appliance over several weeks. This study assesses changes in dental, alveolar, skeletal, and muscular structures by using advanced imaging such as 3D Cone Beam Computed Tomography (CBCT) and surface electromyography (sEMG). Additionally, patient-reported pain and discomfort levels will be evaluated during the orthodontic treatment.
This trial focuses on objectively measuring morphological and functional changes to determine whether magnesium intake enhances the effects of the Alt-RAMEC treatment and improves patient comfort and treatment outcomes. The findings may provide valuable evidence for optimizing management protocols for transverse maxillary deficiency in young adult patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Masking Description:
There are no additional parties masked in this clinical trial. The study is conducted as an open-label trial with no blinding of participants, investigators, or outcome assessors. All parties are aware of the treatment assignments throughout the study.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •All participants were young adults, from the 18- 25 age group (males or females).
- •There is a maxillary skeletal deficiency in every patient. (Anteroposterior deficiency, transverse bilateral/unilateral deficiency)
- •All teeth erupted without any abnormalities in term of shape and size.
- •Good oral hygiene and non-smoking habits.
排除标准
- •History of previous orthodontic treatment or maxillary expansion
- •Patients with severe progressive periodontal disease
- •Patients with severe craniomaxillofacial deformities such as cleft lip and palate
- •Mid palatal fusion without successful expansion
- •First molar absent or impacted in the patient.
- •Patients who have bone loss, gingival recession, or persistent gingival inflammation.
- •Individuals with a high gag reflex.
- •History of a life-threatening medical condition, such as diabetes mellitus, or a chronic disease such as organ transplant rejection or cancer in patients receiving chemotherapy or radiation therapy and high risk of infections.
研究组 & 干预措施
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.
干预措施: Micro-implant-Assisted Rapid Palatal Expansion (MARPE) With the Alt-RAMEC Protocol (Device)
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.
干预措施: Oral Magnesium Citrate Supplementation (Dietary Supplement)
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.
干预措施: Micro-implant-Assisted Rapid Palatal Expansion (MARPE) With the Alt-RAMEC Protocol (Device)
结局指标
主要结局
Change from Baseline in Anterior Midpalatal Suture Separation at 12 Weeks
时间窗: 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.
The Primary Outcome Measure title for this clinical study is: Change in Transverse Maxillary Dimensions and Muscular Activity Following Alt-RAMEC Protocol with or without Magnesium Supplementation
时间窗: The Time Frame for the primary outcome measure in this clinical trial is: Pre-treatment (T0) to Post-treatment (T1), including the active expansion period after 12 weeks of alternate expansion and constriction
Primary Outcome Description: The primary outcome of this study is to assess the changes in transverse maxillary dimensions and muscular activity in adult patients with transverse maxillary deficiency following treatment with the Alternate Maxillary Expansion and Constriction (Alt-RAMEC) protocol using Micro-implant Assisted Rapid Palatal Expansion (MARPE) with or without magnesium supplementation. This includes quantitative measurements of skeletal and dentoalveolar changes using 3D Cone Beam Computed Tomography (CBCT) imaging, evaluation of muscular changes via surface electromyography (sEMG) during dental clench and chewing, and assessment of patient-reported pain and discomfort using a visual analog scale. The study compares these parameters pre-treatment (T0) and post-treatment (T1) to determine the efficacy and effects of the interventions on maxillary expansion and muscular adaptations.
次要结局
- Change from Baseline in Posterior Midpalatal Suture Separation at 12 Weeks(Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).)
研究者
IBRAHEEM RAHMA HAZIM IBRAHEEM
principle invistegator
Universiti Sains Malaysia