Effekterne af magnesiumtilskud (Mg) og alternerende maksillær udvidelse og indsnævring (Alt-RAMEC) hos patienter med transvers maksillær insufficiens (TMD) (Mg + Alt-RAMEC)
13. september 2026 opdateret af: IBRAHEEM RAHMA HAZIM IBRAHEEM, Universiti Sains Malaysia
Effekterne af magnesiumtilskud (Mg) og alternerende maksillær ekspansion og konstriktion (Alt-RAMEC) hos patienter med transversal maksillær defekt (TMD): Et randomiseret klinisk forsøg.
Denne randomiserede kliniske undersøgelse evaluerer effekten af at kombinere magnesiumtilskud med en ortodontisk teknik kaldet Alternate Maxillary Expansion and Constriction (Alt-RAMEC) ved brug af en Micro-implant Assisted Rapid Palatal Expansion (MARPE) apparat til behandling af voksne (18-30 år) med transversal maxillær insufficiens (TMD). TMD er en tilstand, hvor overkæben er smallere end normalt, hvilket kan påvirke bid og ansigtsudvikling.
Undersøgelsen involverer to grupper: en modtager Alt-RAMEC-protokollen med kun MARPE, og den anden modtager den samme protokol sammen med orale magnesiumtilskud. Effektiviteten af disse behandlinger vil blive sammenlignet ved at vurdere ændringer i tand- og skeletstrukturer gennem billeddannende teknikker og evaluere muskel funktion. Deltagerne vil også rapportere deres smerte- og ubehagsniveauer under behandlingen.
Denne forskning har til formål at forstå, om magnesiumtilskud kan forbedre effekterne af Alt-RAMEC-behandlingen, forbedre patientresultater og reducere ubehag forbundet med ortodontiske procedurer.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Dette kliniske forsøg har til formål at evaluere effektiviteten af magnesiumtilskud kombineret med Alternate Maxillary Expansion and Constriction-protokollen (Alt-RAMEC) ved brug af Micro-implant Assisted Rapid Palatal Expansion (MARPE) hos voksne patienter med transvers maxillær insufficiens (TMD). Studiet sammenligner to behandlingsgrupper: den ene modtager Alt-RAMEC-protokollen med MARPE alene, og den anden modtager Alt-RAMEC med MARPE sammen med oral magnesiumtilskud.
Alt-RAMEC-protokollen involverer kontrollerede cyklusser af maxillær udvidelse og indsnævring for at lette korrektionen af transversale maxillære afvigelser. Patienter behandles med specifikke aktiverings- og deaktiveringsregimer, der involverer MARPE-apparatet over flere uger. Dette studie vurderer ændringer i dentale, alveolære, skeletale og muskelske strukturer ved brug af avancerede billeddannelsesteknikker såsom 3D Cone Beam Computed Tomography (CBCT) og overflade-elektromyografi (sEMG). Derudover vil patientrapporterede smerte- og ubehagsniveauer blive evalueret under den ortodontiske behandling.
Dette forsøg fokuserer på objektivt at måle morfologiske og funktionelle ændringer for at afgøre, om magnesiumindtagelse forstærker effekterne af Alt-RAMEC-behandlingen og forbedrer patientkomfort og behandlingsresultater. Resultaterne kan give værdifulde beviser til optimering af behandlingsprotokoller for transvers maxillær insufficiens hos unge voksne patienter.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
38
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Al-Batawen
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Baghdad, Al-Batawen, Irak, 10001
- Dr. Aws Fakhri Alfatlawi specialized Orthodontics Clinic
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
Inklusionskriterier
- Alle deltagere var unge voksne i aldersgruppen 18-25 år (mænd eller kvinder).
- Der er en maxillær skeletmangel hos hver patient. (Anteroposterior mangel, bilateral/unilateral transversal mangel)
- Alle tænder var frembrudte uden nogen unormaliteter i form af form og størrelse.
- God oral hygiejne og ikke-rygevaner.
Eksklusionskriterier:
- Tidligere ortodontisk behandling eller maxillær ekspansion
- Patienter med alvorlig progressiv parodontal sygdom
- Patienter med alvorlige kraniomaxillofaciale deformiteter som læbe- og ganespalte
- Midterpalatal fusion uden vellykket ekspansion
- Første molar fraværende eller impacteret hos patienten.
- Patienter med knogletab, tandkødsrecession eller vedvarende tandkødsbetændelse.
- Personer med en høj gagrefleks.
- Historie med en livstruende medicinsk tilstand, såsom diabetes mellitus, eller en kronisk sygdom som organafstødning efter transplantation eller kræft hos patienter under kemoterapi eller strålebehandling og høj risiko for infektioner.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv 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.
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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.
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Eksperimentel: 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.
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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.
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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline in Anterior Midpalatal Suture Separation at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline in Posterior Midpalatal Suture Separation at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline in Interzygomatic Width at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Maxillary Jugale-to-Jugale Width at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Relative Palatal Expansion Ratio at 12 Weeks
Tidsramme: 12 weeks after the first MARPE activation (T1).
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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.
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12 weeks after the first MARPE activation (T1).
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Change from Baseline in Maxillary Alveolar Width at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Maxillary First-Molar Interfurcation Width at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Right Maxillary First-Molar Inclination at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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).
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Left Maxillary First-Molar Inclination at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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)
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Right Maxillary Alveolar Inclination at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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).
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Buccal Bone Thickness at the Right Maxillary First Molar at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Buccal Bone Thickness at the Left Maxillary First Molar at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Mean Midpalatal CBCT Gray Value at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Maxillary Intercanine Width at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Maxillary Intermolar Width at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Maxillary Anterior Arch Length at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Maxillary Molar-Level Arch Length at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Palatal Width at the Maxillary Canine Level at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Palatal Width at the Maxillary First-Molar Level at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Normalized Right Masseter Activity During Chewing at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Normalized Left Masseter Activity During Chewing at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Normalized Right Anterior Temporalis Activity During Chewing at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Change from Baseline in Normalized Left Anterior Temporalis Activity During Chewing at 12 Weeks
Tidsramme: Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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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.
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Baseline, before the first MARPE activation (T0), and 12 weeks after the first MARPE activation (T1).
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Overall Activation-Period Pain Intensity Assessed at 12 Weeks
Tidsramme: Assessed 12 weeks after the first MARPE activation (T1), recalling pain during the active treatment period.
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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.
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Assessed 12 weeks after the first MARPE activation (T1), recalling pain during the active treatment period.
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Number of Participants by Most Frequent Pain Location During Active Treatment
Tidsramme: Assessed 12 weeks after the first MARPE activation (T1), recalling the most frequent pain location during the active treatment period.
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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.
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Assessed 12 weeks after the first MARPE activation (T1), recalling the most frequent pain location during the active treatment period.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
21. januar 2025
Primær færdiggørelse (Faktiske)
31. december 2025
Studieafslutning (Faktiske)
31. december 2025
Datoer for studieregistrering
Først indsendt
30. november 2025
Først indsendt, der opfyldte QC-kriterier
19. december 2025
Først opslået (Faktiske)
30. december 2025
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- USM/JEPeM/KK/24070610
Plan for individuelle deltagerdata (IPD)
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Derudover er datadeling underlagt etiske godkendelser og aftaler, der begrænser spredningen for at beskytte deltagernes rettigheder.
Denne begrænsning sikrer overholdelse af institutionelle, etiske og juridiske standarder, der regulerer deltagerdatasikkerhed.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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