The Effects of Magnesium (Mg) Supplement and Alternate Maxillary Expansion and Constriction (Alt-RAMEC) in Patient With Transverse Maxillary Deficiency (TMD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: magnesium citrate, Magnesium.
- Who it may be relevant to
- Registry conditions: Magnesium During Orthodontic Expansion, Orthodontic Patients Indicated for Maxillary Expansion. Basic parameters: 18 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Iraq
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
Detailed description
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.
Interventions
- Dietary supplement magnesium citrate
using in orthodontic patients - Dietary supplement Magnesium
Mg supplement provoke more sutural separation and bone integrity (density and thickness) in Alt-Ramec protocol compared to the normal expansion protocol?
Primary outcome measures
- 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 [Time frame: 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Iraq · 1 center
- Faculty of Dental Medicine IBSU University, Baghdad , Iraq — Baghdad
Identifiers
NCT: NCT07309640 · USM/JEPeM/KK/24070610