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

NCT07309640 | Completed DMC

• 1 other identifier: USM/JEPeM/KK/24070610
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orthodontic Patients Indicated for Maxillary Expansion; Magnesium During Orthodontic Expansion

Keywords

Expansion; Magnesium; Orthodontic

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Anterior Midpalatal Suture Separation at 12 Weeks

  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).

Secondary Outcomes (1)

• 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).

Other Outcomes (23)

• Change from Baseline in Interzygomatic Width at 12 Weeks

  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

  Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).

• Relative Palatal Expansion Ratio at 12 Weeks

  12 weeks after the first MARPE activation (T1).

Study Arms (2)

Alt-RAMEC/MARPE Without Magnesium Supplementation

ACTIVE COMPARATOR

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.

Device: Micro-implant-Assisted Rapid Palatal Expansion (MARPE) With the Alt-RAMEC Protocol

Alt-RAMEC/MARPE With Magnesium Citrate Supplementation

EXPERIMENTAL

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.

Dietary Supplement: Oral Magnesium Citrate Supplementation; Device: Micro-implant-Assisted Rapid Palatal Expansion (MARPE) With the Alt-RAMEC Protocol

Interventions

Oral Magnesium Citrate Supplementation DIETARY_SUPPLEMENT

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.

Also known as: Magnesium

Alt-RAMEC/MARPE With Magnesium Citrate Supplementation

Micro-implant-Assisted Rapid Palatal Expansion (MARPE) With the Alt-RAMEC Protocol DEVICE

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.

Alt-RAMEC/MARPE With Magnesium Citrate Supplementation; Alt-RAMEC/MARPE Without Magnesium Supplementation

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Dr. Aws Fakhri Alfatlawi specialized Orthodontics Clinic

Baghdad, Al-Batawen, 10001, Iraq

Location

MeSH Terms

Interventions

Magnesium

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle invistegator

Model Details: Model Description for the Interventional Study Model (Parallel Assignment): 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.

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 30, 2025
• Study Start: January 21, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)