The Effects of Magnesium (Mg) Supplement and Alternate Maxillary Expansion and Constriction (Alt-RAMEC) in Patient With Transverse Maxillary Deficiency (TMD)
NCT ID: NCT07309640
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
38 participants
INTERVENTIONAL
2026-01-01
2026-09-12
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SEQUENTIAL
This randomized clinical trial utilizes a parallel assignment design in which adult patients with transverse maxillary deficiency are randomly allocated into two groups. One group receives the Alternate Maxillary Expansion and Constriction (Alt-RAMEC) protocol using the Micro-implant Assisted Rapid Palatal Expansion (MARPE) appliance alone, while the second group receives the same protocol combined with oral magnesium supplementation.
Both groups undergo the interventions simultaneously but independently, allowing comparison of the outcomes related to dental, skeletal, muscular, and patient-reported factors. The parallel design facilitates the evaluation of the added effect of magnesium supplementation on the efficacy and patient experience during the orthodontic expansion treatment.
This design supports unbiased comparison between intervention effects in two distinct groups treated concurrently.
HEALTH_SERVICES_RESEARCH
NONE
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.
Study Groups
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Control group
Normal expansion activities
magnesium citrate
using in orthodontic patients
Magnesium
Mg supplement provoke more sutural separation and bone integrity (density and thickness) in Alt-Ramec protocol compared to the normal expansion protocol?
Interventions
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magnesium citrate
using in orthodontic patients
Magnesium
Mg supplement provoke more sutural separation and bone integrity (density and thickness) in Alt-Ramec protocol compared to the normal expansion protocol?
Eligibility Criteria
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Inclusion Criteria
2. There is a maxillary skeletal deficiency in every patient. (Anteroposterior deficiency, transverse bilateral/unilateral deficiency)
3. All teeth erupted without any abnormalities in term of shape and size.
4. Good oral hygiene and non-smoking habits.
Exclusion Criteria
2. Patients with severe progressive periodontal disease
3. Patients with severe craniomaxillofacial deformities such as cleft lip and palate
4. Mid palatal fusion without successful expansion
5. First molar absent or impacted in the patient.
6. Patients who have bone loss, gingival recession, or persistent gingival inflammation.
7. Individuals with a high gag reflex.
8. 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.
18 Years
25 Years
ALL
No
Sponsors
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Universiti Sains Malaysia
OTHER
Responsible Party
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IBRAHEEM RAHMA HAZIM IBRAHEEM
principle invistegator
Locations
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Faculty of Dental Medicine IBSU University, Baghdad , Iraq
Baghdad, , Iraq
Countries
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Central Contacts
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Other Identifiers
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USM/JEPeM/KK/24070610
Identifier Type: -
Identifier Source: org_study_id