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

September 13, 2026 updated by: IBRAHEEM RAHMA HAZIM IBRAHEEM, Universiti Sains Malaysia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Iraq
    • Al-Batawen
      • Baghdad, Al-Batawen, Iraq, 10001
        • Dr. Aws Fakhri Alfatlawi specialized Orthodontics Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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:

  1. History of previous orthodontic treatment or maxillary expansion
  2. Patients with severe progressive periodontal disease
  3. Patients with severe craniomaxillofacial deformities such as cleft lip and palate
  4. Mid palatal fusion without successful expansion
  5. First molar absent or impacted in the patient.
  6. Patients who have bone loss, gingival recession, or persistent gingival inflammation.
  7. Individuals with a high gag reflex.
  8. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Alt-RAMEC/MARPE Without Magnesium Supplementation
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.
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.
Experimental: Alt-RAMEC/MARPE With Magnesium Citrate Supplementation
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.
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.
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.
Other Names:
  • Magnesium

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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.
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Interzygomatic Width at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in interzygomatic width measured in millimetres using cone-beam computed tomography (CBCT). Interzygomatic width is the distance between the anterior outer points of the right and left zygomaticomaxillary sutures on a standardized axial section. Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0). Positive values indicate increased transverse width.
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change from Baseline in Maxillary Jugale-to-Jugale Width at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in the transverse distance between the right and left jugale landmarks, measured in millimetres using cone-beam computed tomography (CBCT). Each jugale landmark is identified at the intersection of the outlines of the maxillary tuberosity and zygomatic process on a standardized coronal section. Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0). Positive values indicate increased maxillary width.
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Relative Palatal Expansion Ratio at 12 Weeks
Time Frame: 12 weeks after the first MARPE activation (T1).
The proportion of mechanical expansion expressed as skeletal midpalatal suture opening. The mean change in suture separation at the anterior nasal spine (ANS) and posterior nasal spine (PNS), measured using cone-beam computed tomography, is divided by the recorded mechanical expansion of the MARPE screw in millimetres. The calculation is [(ANS change + PNS change)/2]/mechanical expansion. The outcome is reported as a unitless ratio (mm/mm). Higher values indicate greater skeletal opening per unit of mechanical expansion.
12 weeks after the first MARPE activation (T1).
Change from Baseline in Maxillary Alveolar Width at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in maxillary alveolar width measured in millimetres using cone-beam computed tomography (CBCT). Alveolar width is measured between the right and left buccal alveolar bone surfaces on a standardized coronal section along the line connecting the maxillary first-molar furcations. Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0). Positive values indicate increased alveolar width.
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change from Baseline in Maxillary First-Molar Interfurcation Width at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in the distance between the furcations of the right and left maxillary first molars, measured in millimetres using cone-beam computed tomography (CBCT). Measurements are obtained on standardized coronal sections showing both furcations. Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0). Positive values indicate increased interfurcation width.
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change from Baseline in Right Maxillary First-Molar Inclination at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in the inclination of the right maxillary first molar, measured in degrees using cone-beam computed tomography (CBCT). Inclination is the angle between the palatal reference line and the palatal root axis, defined by the root apex and canal orifice, on a standardized coronal section. Change is calculated as the angle at 12 weeks (T1) minus the baseline angle (T0).
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change from Baseline in Left Maxillary First-Molar Inclination at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in the inclination of the left maxillary first molar, measured in degrees using cone-beam computed tomography (CBCT). Inclination is the angle between the palatal reference line and the palatal root axis, defined by the root apex and canal orifice, on a standardized coronal section. Change is calculated as the angle at 12 weeks (T1) minus the baseline angle (T0)
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change from Baseline in Right Maxillary Alveolar Inclination at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in right maxillary alveolar inclination, measured in degrees using cone-beam computed tomography (CBCT). Alveolar inclination is the angle between the right palatal alveolar bone and the palatal plane on a standardized coronal section. Change is calculated as the angle at 12 weeks (T1) minus the baseline angle (T0).
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change from Baseline in Buccal Bone Thickness at the Right Maxillary First Molar at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in buccal bone thickness at the right maxillary first molar, measured in millimetres using cone-beam computed tomography (CBCT). Thickness is measured from the root surface to the outer buccal bone surface at the first-molar trifurcation level on a standardized coronal section. Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0). Negative values indicate reduced buccal bone thickness.
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change from Baseline in Buccal Bone Thickness at the Left Maxillary First Molar at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in buccal bone thickness at the left maxillary first molar, measured in millimetres using cone-beam computed tomography (CBCT). Thickness is measured from the root surface to the outer buccal bone surface at the first-molar trifurcation level on a standardized coronal section. Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0). Negative values indicate reduced buccal bone thickness.
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change from Baseline in Mean Midpalatal CBCT Gray Value at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in the mean cone-beam computed tomography (CBCT) gray value within a standardized 4-mm-diameter region of interest centered on the midpalatal suture at the level of the line connecting the palatal roots of the maxillary first molars. Corresponding regions are assessed at baseline and 12 weeks using standardized image orientation. Change is calculated as the mean gray value at T1 minus the mean gray value at T0 and is reported in CBCT gray-value units. This measurement is a relative radiographic density proxy, not calibrated bone mineral density.
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change from Baseline in Maxillary Intercanine Width at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in maxillary intercanine width measured in millimetres on digital dental models obtained by intraoral scanning. Intercanine width is the distance between the cusp tips of the right and left maxillary canines. Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0). Positive values indicate increased intercanine width.
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change from Baseline in Maxillary Intermolar Width at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in maxillary intermolar width measured in millimetres on digital dental models obtained by intraoral scanning. Intermolar width is the distance between the mesiobuccal cusp tips of the right and left maxillary first molars. Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0). Positive values indicate increased intermolar width.
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change from Baseline in Maxillary Anterior Arch Length at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in maxillary anterior arch length measured in millimetres on digital dental models. Anterior arch length is the perpendicular distance from the line joining the right and left maxillary canine cusp tips to the most prominent maxillary central-incisor point. Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0). Positive values indicate increased anterior arch length.
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change from Baseline in Maxillary Molar-Level Arch Length at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in maxillary arch length at the first-molar level, measured in millimetres on digital dental models. The measurement is the perpendicular distance from the line joining the mesiobuccal cusp tips of the right and left maxillary first molars to the most prominent maxillary central-incisor point. Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0). Positive values indicate increased arch length.
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change from Baseline in Palatal Width at the Maxillary Canine Level at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in palatal width at the maxillary canine level, measured in millimetres on digital dental models. Width is measured between the right and left palatal gingival-margin midpoints at the maxillary canines. Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0). Positive values indicate increased palatal width at the canine level.
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change from Baseline in Palatal Width at the Maxillary First-Molar Level at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in palatal width at the maxillary first-molar level, measured in millimetres on digital dental models. Width is measured between the right and left palatal gingival-margin points corresponding to the centers of the mesiopalatal cusps of the maxillary first molars. Change is calculated as the measurement at 12 weeks (T1) minus the baseline measurement (T0). Positive values indicate increased palatal width at the first-molar level.
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change from Baseline in Normalized Right Masseter Activity During Chewing at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in normalized surface electromyographic activity of the right masseter muscle during a standardized chewing task. At each assessment, the root mean square (RMS) amplitude during chewing is divided by the same muscle's RMS amplitude during maximum voluntary clenching in intercuspation, recorded during the same session, and multiplied by 100. Change is calculated as the normalized value at 12 weeks (T1) minus the baseline value (T0) and is expressed in percentage points of maximum voluntary clench-normalized activity.
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change from Baseline in Normalized Left Masseter Activity During Chewing at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in normalized surface electromyographic activity of the left masseter muscle during a standardized chewing task. At each assessment, the root mean square (RMS) amplitude during chewing is divided by the same muscle's RMS amplitude during maximum voluntary clenching in intercuspation, recorded during the same session, and multiplied by 100. Change is calculated as the normalized value at 12 weeks (T1) minus the baseline value (T0) and is expressed in percentage points of maximum voluntary clench-normalized activity.
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change from Baseline in Normalized Right Anterior Temporalis Activity During Chewing at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in normalized surface electromyographic activity of the right anterior temporalis muscle during a standardized chewing task. At each assessment, the root mean square (RMS) amplitude during chewing is divided by the same muscle's RMS amplitude during maximum voluntary clenching in intercuspation, recorded during the same session, and multiplied by 100. Change is calculated as the normalized value at 12 weeks (T1) minus the baseline value (T0) and is expressed in percentage points of maximum voluntary clench-normalized activity.
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change from Baseline in Normalized Left Anterior Temporalis Activity During Chewing at 12 Weeks
Time Frame: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Change in normalized surface electromyographic activity of the left anterior temporalis muscle during a standardized chewing task. At each assessment, the root mean square (RMS) amplitude during chewing is divided by the same muscle's RMS amplitude during maximum voluntary clenching in intercuspation, recorded during the same session, and multiplied by 100. Change is calculated as the normalized value at 12 weeks (T1) minus the baseline value (T0) and is expressed in percentage points of maximum voluntary clench-normalized activity.
Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
Overall Activation-Period Pain Intensity Assessed at 12 Weeks
Time Frame: Assessed 12 weeks after the first MARPE activation (T1), recalling pain during the active treatment period.
Participant-reported overall pain intensity experienced during the active alternate maxillary expansion and constriction (Alt-RAMEC) treatment period, assessed at the 12-week visit using a 0-10 pain intensity scale. A score of 0 indicates no pain or discomfort, and a score of 10 indicates the worst imaginable pain or discomfort. Higher scores indicate greater pain intensity. The outcome is reported in scale points and represents recalled overall activation-period pain, not a change from baseline.
Assessed 12 weeks after the first MARPE activation (T1), recalling pain during the active treatment period.
Number of Participants by Most Frequent Pain Location During Active Treatment
Time Frame: Assessed 12 weeks after the first MARPE activation (T1), recalling the most frequent pain location during the active treatment period.
The most frequent location of pain experienced during the active alternate maxillary expansion and constriction (Alt-RAMEC) treatment period, reported using a structured questionnaire at the 12-week visit. Participants select one location: anterior palate, posterior palate, molar region, or zygomatic region. The outcome is reported as the number of participants selecting each location.
Assessed 12 weeks after the first MARPE activation (T1), recalling the most frequent pain location during the active treatment period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Sains Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • USM/JEPeM/KK/24070610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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