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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorUniversiti Sains Malaysia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • magnesium citrate

    Dietary supplement

    using in orthodontic patients

  • 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?

Treatment groups

38 Participants
are divided into 1 treatment group
Group A: Control groupOther 2 interventions

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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