The Effects of Magnesium (Mg) Supplement and Alternate Maxillary Expansion and Constriction (Alt-RAMEC) in Patient With Transverse Maxillary Deficiency (TMD)

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка magnesium citrate
  using in orthodontic patients
• Пищевая добавка Magnesium
  Mg supplement provoke more sutural separation and bone integrity (density and thickness) in Alt-Ramec protocol compared to the normal expansion protocol?

Первичные конечные точки

• 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 [Срок оценки: 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]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Ирак · 1 центр

• Faculty of Dental Medicine IBSU University, Baghdad , Iraq — Baghdad

Идентификаторы

NCT: NCT07309640 · USM/JEPeM/KK/24070610

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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