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 volunteersQualifiers
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
Sequential
Treatments tested in this trial
magnesium citrate
Dietary supplementusing in orthodontic patients
Magnesium
Dietary supplementMg supplement provoke more sutural separation and bone integrity (density and thickness) in Alt-Ramec protocol compared to the normal expansion protocol?
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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