Magnesium During Orthodontic ExpansionMg + Alt-RAMECNCT07309640
The Effects of Magnesium (Mg) Supplement and Alternate Maxillary Expansion and Constriction (Alt-RAMEC) in Patient With Transverse Maxillary Deficiency (TMD)
A study testing Oral Magnesium Citrate Supplementation and Micro-implant-Assisted Rapid Palatal Expansion (MARPE) With the Alt-RAMEC Protocol in people with Magnesium During Orthodontic Expansion and Orthodontic Patients Indicated for Maxillary Expansion, run by Universiti Sains Malaysia at 1 site in Iraq.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Magnesium During Orthodontic Expansion, Orthodontic Patients Indicated for Maxillary Expansion
- What is being tested?
- Oral Magnesium Citrate Supplementation and Micro-implant-Assisted Rapid Palatal Expansion (MARPE) With the Alt-RAMEC Protocol
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteIraq
- Study dates
- 21 Jan 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Dr. Aws Fakhri Alfatlawi specialized Orthodontics Clinic
Baghdad, Al-Batawen, 10001
About this study
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.
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.
Read the detailed 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.
- Conditions
- Magnesium During Orthodontic Expansion, Orthodontic Patients Indicated for Maxillary Expansion
- Being tested
- Oral Magnesium Citrate Supplementation, Micro-implant-Assisted Rapid Palatal Expansion (MARPE) With the Alt-RAMEC Protocol
- Keywords
- Expansion, Magnesium, Orthodontic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Magnesium Citrate SupplementationDietary supplement
Also called Magnesium
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.
Micro-implant-Assisted Rapid Palatal Expansion (MARPE) With the Alt-RAMEC ProtocolDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Alt-RAMEC/MARPE Without Magnesium Supplementation | Active comparator | Participants receive alternate rapid maxillary expansion and constriction (Alt-RAMEC) using a micro-implant-assisted rapid palatal expansion (MARPE) appliance without magnesium supplementation. The appliance consists of a 10-mm Maxillary Skeletal Expander II supported by four palatal miniscrews. 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 appliance and activation schedule are identical to those used in the experimental arm; this arm serves as the control for evaluating the additional effects of magnesium supplementation. Receives: Device: Micro-implant-Assisted Rapid Palatal Expansion (MARPE) With the Alt-RAMEC Protocol |
| Alt-RAMEC/MARPE With Magnesium Citrate Supplementation | Experimental | Participants receive alternate rapid maxillary expansion and constriction (Alt-RAMEC) using a micro-implant-assisted rapid palatal expansion (MARPE) appliance, together with oral magnesium citrate providing 400 mg of elemental magnesium daily, administered as three capsules with food for 12 weeks from the first day of activation. The appliance consists of a 10-mm Maxillary Skeletal Expander II supported by four palatal miniscrews. 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, while magnesium supplementation continues. Receives: Dietary Supplement: Oral Magnesium Citrate Supplementation; Device: Micro-implant-Assisted Rapid Palatal Expansion (MARPE) With the Alt-RAMEC Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Anterior Midpalatal Suture Separation at 12 Weeks
Change in anterior midpalatal suture separation measured in millimetres (mm) using cone-beam computed tomography (CBCT) at the anterior nasal spine (ANS) level. Measurements are assessed before the first activation of micro-implant-assisted rapid palatal expansion (MARPE; T0) and 12 weeks after activation begins (T1). The change is calculated as the T1 measurement minus the T0 measurement. Positive values indicate increased separation at the anterior part of the midpalatal suture. Changes are compared between participants receiving the alternate maxillary expansion and constriction (Alt-RAMEC) protocol with magnesium supplementation and those receiving the same protocol without magnesium supplementation.
Measured: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Secondary outcomes (1)
Change from Baseline in Posterior Midpalatal Suture Separation at 12 Weeks
Change in posterior midpalatal suture separation measured in millimetres (mm) using cone-beam computed tomography (CBCT) at the posterior nasal spine (PNS) level. Measurements are assessed before the first activation of micro-implant-assisted rapid palatal expansion (MARPE; T0) and 12 weeks after activation begins (T1). The change is calculated as the T1 measurement minus the T0 measurement. Positive values indicate increased separation at the posterior part of the midpalatal suture. Changes are compared between participants receiving the alternate maxillary expansion and constriction (Alt-RAMEC) protocol with magnesium supplementation and those receiving the same protocol without magnesium supplementation.
Measured: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start21 Jan 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnesium During Orthodontic ExpansionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IBRAHEEM RAHMA HAZIM IBRAHEEM, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309640
- Sponsor's protocol ID
- USM/JEPeM/KK/24070610
- Acronym
- Mg + Alt-RAMEC
- Status last verified
- Sep 2026
- First submitted
- 30 Nov 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared outside the research team due to concerns related to protecting patient confidentiality and privacy. The data contains sensitive health information, and sharing it could pose risks despite de-identification efforts. Additionally, data sharing is subject to ethical approvals and agreements that limit dissemination to safeguard participants' rights. This restriction ensures compliance with institutional, ethical, and legal standards governing participant data security.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07309640
- Acronym / sponsor ID
- Mg + Alt-RAMEC / USM/JEPeM/KK/24070610
- Conditions
- Magnesium During Orthodontic Expansion, Orthodontic Patients Indicated for Maxillary Expansion
- Keywords
- Expansion, Magnesium, Orthodontic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Alt-RAMEC/MARPE Without Magnesium Supplementation | Active comparator | Device: Micro-implant-Assisted Rapid Palatal Expansion (MARPE) With the Alt-RAMEC ProtocolParticipants receive alternate rapid maxillary expansion and constriction (Alt-RAMEC) using a micro-implant-assisted rapid palatal expansion (MARPE) appliance without magnesium supplementation. The appliance consists of a 10-mm Maxillary Skeletal Expander II supported by four palatal miniscrews. 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 appliance and activation schedule are identical to those used in the experimental arm; this arm serves as the control for evaluating the additional effects of magnesium supplementation. |
| Alt-RAMEC/MARPE With Magnesium Citrate Supplementation | Experimental | Dietary Supplement: Oral Magnesium Citrate Supplementation, Device: Micro-implant-Assisted Rapid Palatal Expansion (MARPE) With the Alt-RAMEC ProtocolParticipants receive alternate rapid maxillary expansion and constriction (Alt-RAMEC) using a micro-implant-assisted rapid palatal expansion (MARPE) appliance, together with oral magnesium citrate providing 400 mg of elemental magnesium daily, administered as three capsules with food for 12 weeks from the first day of activation. The appliance consists of a 10-mm Maxillary Skeletal Expander II supported by four palatal miniscrews. 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, while magnesium supplementation continues. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Magnesium Citrate SupplementationAlso: MagnesiumParticipants 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. | Dietary supplement | Alt-RAMEC/MARPE With Magnesium Citrate Supplementation |
| Micro-implant-Assisted Rapid Palatal Expansion (MARPE) With the Alt-RAMEC ProtocolParticipants 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. | Device | Alt-RAMEC/MARPE With Magnesium Citrate Supplementation, Alt-RAMEC/MARPE Without Magnesium Supplementation |
Primary outcome
Change from Baseline in Anterior Midpalatal Suture Separation at 12 Weeks
Time frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in anterior midpalatal suture separation measured in millimetres (mm) using cone-beam computed tomography (CBCT) at the anterior nasal spine (ANS) level. Measurements are assessed before the first activation of micro-implant-assisted rapid palatal expansion (MARPE; T0) and 12 weeks after activation begins (T1). The change is calculated as the T1 measurement minus the T0 measurement. Positive values indicate increased separation at the anterior part of the midpalatal suture. Changes are compared between participants receiving the alternate maxillary expansion and constriction (Alt-RAMEC) protocol with magnesium supplementation and those receiving the same protocol without magnesium supplementation.
1 secondary outcome
Change from Baseline in Posterior Midpalatal Suture Separation at 12 Weeks
Time frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared outside the research team due to concerns related to protecting patient confidentiality and privacy. The data contains sensitive health information, and sharing it could pose risks despite de-identification efforts. Additionally, data sharing is subject to ethical approvals and agreements that limit dissemination to safeguard participants' rights. This restriction ensures compliance with institutional, ethical, and legal standards governing participant data security.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Magnesium Citrate Supplementation and Micro-implant-Assisted Rapid Palatal Expansion (MARPE) With the Alt-RAMEC Protocol in people with Magnesium During Orthodontic Expansion and Orthodontic Patients Indicated for Maxillary Expansion, run by Universiti Sains Malaysia at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Anterior Midpalatal Suture Separation at 12 Weeks (time frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.