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

Universiti Sains Malaysia

Status

Not yet enrolling

Conditions

Magnesium During Orthodontic Expansion

Orthodontic Patients Indicated for Maxillary Expansion

Treatments

Dietary Supplement: magnesium citrate

Dietary Supplement: Magnesium

Study type

Interventional

Funder types

Other

Identifiers

NCT07309640

USM/JEPeM/KK/24070610

Details and patient eligibility

About

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.

Full 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.

Enrollment

38 estimated patients

Sex

All

Ages

18 to 25 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Inclusion Criteria
1. All participants were young adults, from the 18- 25 age group (males or females).
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

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.