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De effecten van magnesiumsupplement en alternatieve maxillaire expansie en vernauwing (Alt-RAMEC) bij patiënten met transversale maxillaire deficiëntie (TMD) (Mg + Alt-RAMEC)

13 september 2026 bijgewerkt door: IBRAHEEM RAHMA HAZIM IBRAHEEM, Universiti Sains Malaysia

De Effecten van Magnesium (Mg) Supplement en Alternerende Maxillaire Expansie en Constrictie (Alt-RAMEC) bij Patiënten met Transversale Maxillaire Deficiëntie (TMD): Een Gerandomiseerde Klinische Studie.

Deze gerandomiseerde klinische studie onderzoekt het effect van het combineren van magnesiumsuppletie met een orthodontische techniek genaamd Alternate Maxillary Expansion and Constriction (Alt-RAMEC) met behulp van een Micro-implant Assisted Rapid Palatal Expansion (MARPE) apparaat om volwassenen (18-30 jaar) met transversale maxillaire deficiëntie (TMD) te behandelen. TMD is een aandoening waarbij de bovenkaak smaller is dan normaal, wat de beet en gezichtsontwikkeling kan beïnvloeden.

De studie omvat twee groepen: één groep die het Alt-RAMEC-protocol met alleen MARPE krijgt, en de andere groep die hetzelfde protocol krijgt samen met orale magnesiumsupplementen. De effectiviteit van deze behandelingen wordt vergeleken door veranderingen in tand- en skeletstructuren te beoordelen via beeldvormingstechnieken en door spierfunctie te evalueren. Deelnemers zullen ook hun pijn- en ongemaksniveaus tijdens de behandeling rapporteren.

Dit onderzoek heeft als doel te begrijpen of magnesiumsuppletie de effecten van Alt-RAMEC-behandeling kan versterken, patiëntuitkomsten kan verbeteren en ongemak geassocieerd met orthodontische procedures kan verminderen.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Deze klinische studie heeft tot doel de effectiviteit te evalueren van magnesiumsuppletie gecombineerd met het Alternate Maxillary Expansion and Constriction (Alt-RAMEC)-protocol met behulp van Micro-implant Assisted Rapid Palatal Expansion (MARPE) bij volwassen patiënten met transversale maxillaire deficiëntie (TMD). De studie vergelijkt twee behandelgroepen: één die het Alt-RAMEC-protocol met alleen MARPE ontvangt, en de andere die Alt-RAMEC met MARPE naast orale magnesiumsuppletie krijgt.

Het Alt-RAMEC-protocol omvat gecontroleerde cycli van maxillaire expansie en vernauwing om de correctie van transversale maxillaire discrepanties te vergemakkelijken. Patiënten worden behandeld met specifieke activatie- en deactivatieschema's met behulp van het MARPE-apparaat gedurende enkele weken. Deze studie beoordeelt veranderingen in dentale, alveolaire, skeletale en spierstructuren door geavanceerde beeldvorming zoals 3D Cone Beam Computed Tomography (CBCT) en oppervlakte-elektromyografie (sEMG) te gebruiken. Daarnaast zullen door patiënten gerapporteerde pijn- en ongemaksniveaus worden geëvalueerd tijdens de orthodontische behandeling.

Deze proef richt zich op het objectief meten van morfologische en functionele veranderingen om te bepalen of magnesiuminname de effecten van de Alt-RAMEC-behandeling versterkt en het patiëntcomfort en de behandelresultaten verbetert. De bevindingen kunnen waardevol bewijs leveren voor het optimaliseren van behandelprotocollen voor transversale maxillaire deficiëntie bij jonge volwassen patiënten.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

38

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Insluitingscriteria:

  • Insluitingscriteria

    1. Alle deelnemers waren jongvolwassenen uit de leeftijdsgroep 18-25 jaar (mannen of vrouwen).
    2. Er is bij elke patiënt een maxillaire skeletale deficiëntie. (Anteroposterieure deficiëntie, transversale bilaterale/unilaterale deficiëntie)
    3. Alle tanden zijn doorgekomen zonder afwijkingen in vorm en grootte.
    4. Goede mondhygiëne en niet-rokersgewoonten.

Uitsluitingscriteria:

  1. Geschiedenis van eerdere orthodontische behandeling of maxillaire expansie
  2. Patiënten met ernstige progressieve parodontale ziekte
  3. Patiënten met ernstige craniomaxillofaciale misvormingen zoals gespleten lip en gehemelte
  4. Middenpalatale fusie zonder succesvolle expansie
  5. Eerste molaar afwezig of geïmpacteerd bij de patiënt.
  6. Patiënten met botverlies, gingivale recessie of aanhoudende gingivale ontsteking.
  7. Personen met een sterke kokhalsreflex.
  8. Geschiedenis van een levensbedreigende medische aandoening, zoals diabetes mellitus, of een chronische ziekte zoals orgaantransplantatie-afstoting of kanker bij patiënten die chemotherapie of radiotherapie ondergaan en een hoog risico op infecties hebben.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Apparaat: 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.
Experimenteel: 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.
Apparaat: 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.
Voedingssupplement: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline in Anterior Midpalatal Suture Separation at 12 Weeks
Tijdsspanne: 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).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline in Posterior Midpalatal Suture Separation at 12 Weeks
Tijdsspanne: 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 uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline in Interzygomatic Width at 12 Weeks
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Universiti Sains Malaysia

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

21 januari 2025

Primaire voltooiing (Werkelijk)

31 december 2025

Studie voltooiing (Werkelijk)

31 december 2025

Studieregistratiedata

Eerst ingediend

30 november 2025

Eerst ingediend dat voldeed aan de QC-criteria

19 december 2025

Eerst geplaatst (Werkelijk)

30 december 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 september 2026

Laatste update ingediend die voldeed aan QC-criteria

13 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • USM/JEPeM/KK/24070610

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individuele deelnemersdata (IPD) zal niet buiten het onderzoeksteam worden gedeeld vanwege zorgen met betrekking tot het beschermen van de vertrouwelijkheid en privacy van patiënten. De data bevat gevoelige gezondheidsinformatie, en delen ervan kan risico's opleveren ondanks inspanningen tot de-identificatie. Bovendien is het delen van data onderworpen aan ethische goedkeuringen en overeenkomsten die de verspreiding beperken om de rechten van deelnemers te beschermen. Deze beperking zorgt voor naleving van institutionele, ethische en wettelijke normen die de beveiliging van deelnemersdata regelen.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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