Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Die Auswirkungen von Magnesium (Mg)-Supplement und alternierender maxillärer Expansion und Konstriktion (Alt-RAMEC) bei Patienten mit transversaler maxillärer Insuffizienz (TMD) (Mg + Alt-RAMEC)

13. September 2026 aktualisiert von: IBRAHEEM RAHMA HAZIM IBRAHEEM, Universiti Sains Malaysia

Die Auswirkungen von Magnesium (Mg)-Supplement und alternativer maxillärer Expansion und Konstriktion (Alt-RAMEC) bei Patienten mit transversaler maxillärer Insuffizienz (TMD): Eine randomisierte klinische Studie.

Diese randomisierte klinische Studie untersucht die Wirkung der Kombination von Magnesiumsupplementierung mit einer kieferorthopädischen Technik namens Alternate Maxillary Expansion and Constriction (Alt-RAMEC) unter Verwendung eines Mikroimplantat-gestützten Geräts zur schnellen Gaumenexpansion (MARPE) zur Behandlung von Erwachsenen (18-30 Jahre) mit transversaler Oberkieferdefizienz (TMD). TMD ist ein Zustand, bei dem der Oberkiefer schmaler als normal ist, was den Biss und die Gesichtsentwicklung beeinträchtigen kann.

Die Studie umfasst zwei Gruppen: eine erhält das Alt-RAMEC-Protokoll mit MARPE allein, die andere erhält dasselbe Protokoll zusammen mit oralen Magnesiumpräparaten. Die Wirksamkeit dieser Behandlungen wird durch die Bewertung von Veränderungen der dentalen und skelettalen Strukturen mittels bildgebender Verfahren und die Auswertung der Muskelfunktion verglichen. Die Teilnehmer werden auch ihre Schmerz- und Unbehaglichkeitsniveaus während der Behandlung melden.

Diese Forschung zielt darauf ab zu verstehen, ob Magnesiumsupplementierung die Wirkung der Alt-RAMEC-Behandlung verbessern, die Behandlungsergebnisse der Patienten steigern und das mit kieferorthopädischen Eingriffen verbundene Unbehagen verringern kann.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Diese klinische Studie zielt darauf ab, die Wirksamkeit von Magnesiumsupplementierung in Kombination mit dem Alternate Maxillary Expansion and Constriction (Alt-RAMEC)-Protokoll unter Verwendung von Micro-implant Assisted Rapid Palatal Expansion (MARPE) bei erwachsenen Patienten mit transversaler Oberkieferdefizienz (TMD) zu bewerten. Die Studie vergleicht zwei Behandlungsgruppen: eine erhält das Alt-RAMEC-Protokoll mit MARPE allein, die andere erhält Alt-RAMEC mit MARPE zusammen mit oraler Magnesiumsupplementierung.

Das Alt-RAMEC-Protokoll umfasst kontrollierte Zyklen von Oberkieferexpansion und -verengung, um die Korrektur von transversalen Oberkieferdiskrepanzen zu erleichtern. Patienten werden über mehrere Wochen mit spezifischen Aktivierungs- und Deaktivierungsregimen unter Verwendung der MARPE-Vorrichtung behandelt. Diese Studie bewertet Veränderungen in dentalen, alveolären, skeletalen und muskulären Strukturen durch den Einsatz fortschrittlicher Bildgebung wie 3D Cone Beam Computed Tomography (CBCT) und Oberflächenelektromyographie (sEMG). Zusätzlich werden patientenberichtete Schmerz- und Unbehagensniveaus während der kieferorthopädischen Behandlung bewertet.

Diese Studie konzentriert sich auf die objektive Messung morphologischer und funktioneller Veränderungen, um zu bestimmen, ob die Magnesiumaufnahme die Effekte der Alt-RAMEC-Behandlung verstärkt und den Patientenkomfort sowie die Behandlungsergebnisse verbessert. Die Ergebnisse könnten wertvolle Beweise für die Optimierung von Managementprotokollen für transversale Oberkieferdefizienz bei jungen erwachsenen Patienten liefern.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

38

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

  • Einschlusskriterien

    1. Alle Teilnehmer waren junge Erwachsene aus der Altersgruppe 18-25 Jahre (männlich oder weiblich).
    2. Bei jedem Patienten liegt ein maxillärer Skelettdefizit vor. (Anteroposteriores Defizit, transversales beidseitiges/einseitiges Defizit)
    3. Alle Zähne sind ohne Anomalien in Form und Größe durchgebrochen.
    4. Gute Mundhygiene und Nichtrauchergewohnheiten.

Ausschlusskriterien:

  1. Anamnese einer früheren kieferorthopädischen Behandlung oder Gaumennahterweiterung
  2. Patienten mit schwerer progressiver Parodontalerkrankung
  3. Patienten mit schweren kraniomaxillofazialen Deformitäten wie Lippen-Kiefer-Gaumenspalte
  4. Gaumennahterweiterung ohne erfolgreiche Expansion
  5. Erster Molar beim Patienten fehlend oder retiniert.
  6. Patienten mit Knochenverlust, Zahnfleischrückgang oder persistierender Gingivitis.
  7. Personen mit starkem Würgereflex.
  8. Anamnese einer lebensbedrohlichen Erkrankung wie Diabetes mellitus oder einer chronischen Erkrankung wie Organabstoßung nach Transplantation oder Krebs bei Patienten unter Chemo- oder Strahlentherapie und hohem Infektionsrisiko.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Gerät: 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.
Gerät: 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.
Nahrungsergänzungsmittel: 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.
Andere Namen:
  • Magnesium

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from Baseline in Anterior Midpalatal Suture Separation at 12 Weeks
Zeitfenster: 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).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from Baseline in Posterior Midpalatal Suture Separation at 12 Weeks
Zeitfenster: 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).

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from Baseline in Interzygomatic Width at 12 Weeks
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Universiti Sains Malaysia

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

21. Januar 2025

Primärer Abschluss (Tatsächlich)

31. Dezember 2025

Studienabschluss (Tatsächlich)

31. Dezember 2025

Studienanmeldedaten

Zuerst eingereicht

30. November 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Dezember 2025

Zuerst gepostet (Tatsächlich)

30. Dezember 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • USM/JEPeM/KK/24070610

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual Participant Data (IPD) wird aufgrund von Bedenken hinsichtlich des Schutzes der Vertraulichkeit und Privatsphäre der Patienten nicht außerhalb des Forschungsteams geteilt. Die Daten enthalten sensible Gesundheitsinformationen, und ihre Weitergabe könnte trotz Anonymisierungsbemühungen Risiken darstellen. Darüber hinaus unterliegt die Datenweitergabe ethischen Genehmigungen und Vereinbarungen, die die Verbreitung einschränken, um die Rechte der Teilnehmer zu schützen. Diese Einschränkung stellt die Einhaltung institutioneller, ethischer und gesetzlicher Standards zur Sicherheit der Teilnehmerdaten sicher.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren