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COMPLETED
NCT07309640
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The Effects of Magnesium (Mg) Supplement and Alternate Maxillary Expansion and Constriction (Alt-RAMEC) in Patient With Transverse Maxillary Deficiency (TMD)

Sponsor: Universiti Sains Malaysia

View on ClinicalTrials.gov

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.

Official title: The Effects of Magnesium (Mg) Supplement and Alternate Maxillary Expansion and Constriction (Alt-RAMEC) in Patient With Transverse Maxillary Deficiency (TMD): A Randomized Clinical Trial.

Key Details

Gender

All

Age Range

18 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2025-01-21

Completion Date

2025-12-31

Last Updated

2026-09-16

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Oral Magnesium Citrate Supplementation

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.

DEVICE

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

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.

Locations (1)

Dr. Aws Fakhri Alfatlawi specialized Orthodontics Clinic

Baghdad, Al-Batawen, Iraq