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

NCT07309640 | Not Yet Recruiting 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)

• 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

  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.

  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

Study Arms (1)

Control group

OTHER

Normal expansion activities

Dietary Supplement: magnesium citrate; Dietary Supplement: Magnesium

Interventions

magnesium citrate DIETARY_SUPPLEMENT

using in orthodontic patients

Control group

Magnesium DIETARY_SUPPLEMENT

Mg supplement provoke more sutural separation and bone integrity (density and thickness) in Alt-Ramec protocol compared to the normal expansion protocol?

Control group

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)

Faculty of Dental Medicine IBSU University, Baghdad , Iraq

Baghdad, 89XH+47Q, Iraq

Location

MeSH Terms

Interventions

magnesium citrate; Magnesium

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Rahma Hazim Al-Hussainy, MSc

CONTACT

+9647732452128; rahma_haz111@student.usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• 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 1, 2026
• Primary Completion (Estimated): August 12, 2026
• Study Completion (Estimated): September 12, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)