Effektene av magnesiumtilskudd (Mg) og alternerende maksillær ekspansjon og innsnøring (Alt-RAMEC) hos pasienter med tverrgående maksillær mangel (TMD) (Mg + Alt-RAMEC)
13. september 2026 oppdatert av: IBRAHEEM RAHMA HAZIM IBRAHEEM, Universiti Sains Malaysia
Effektene av magnesiumtilskudd (Mg) og alternerende maksillær ekspansjon og konstruksjon (Alt-RAMEC) hos pasienter med tverrgående maksillær defisiens (TMD): En randomisert klinisk studie.
Denne randomiserte kliniske studien evaluerer effekten av å kombinere magnesiumtilskudd med en ortodontisk teknikk kalt Alternate Maxillary Expansion and Constriction (Alt-RAMEC) ved bruk av et Micro-implant Assisted Rapid Palatal Expansion (MARPE)-apparat for å behandle voksne (18-30 år) med tverrgående maksillær insuffisiens (TMD). TMD er en tilstand der overkjeven er smalere enn normalt, noe som kan påvirke bitt og ansiktsutvikling.
Studien involverer to grupper: én som mottar Alt-RAMEC-protokollen med kun MARPE, og en annen som mottar samme protokoll sammen med orale magnesiumtilskudd. Effektiviteten av disse behandlingene vil bli sammenlignet ved å vurdere endringer i tann- og skjelettstrukturer gjennom bildebehandlingsteknikker og evaluere muskelfunksjon. Deltakerne vil også rapportere sine smerte- og ubehagsnivåer under behandlingen.
Denne forskningen har som mål å forstå om magnesiumtilskudd kan forbedre effektene av Alt-RAMEC-behandlingen, forbedre pasientresultater og redusere ubehag knyttet til ortodontiske prosedyrer.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
Denne kliniske studien har som mål å evaluere effektiviteten av magnesiumtilskudd kombinert med Alternate Maxillary Expansion and Constriction (Alt-RAMEC)-protokollen ved bruk av Micro-implant Assisted Rapid Palatal Expansion (MARPE) hos voksne pasienter med tverrgående maksillær defisiens (TMD). Studien sammenligner to behandlingsgrupper: en som mottar Alt-RAMEC-protokollen med MARPE alene, og en annen som mottar Alt-RAMEC med MARPE sammen med oralt magnesiumtilskudd.
Alt-RAMEC-protokollen involverer kontrollerte sykluser av maksillær ekspansjon og konstriksjon for å fremme korreksjon av tverrgående maksillære avvik. Pasienter behandles med spesifikke aktiverings- og deaktiveringsregimer som involverer MARPE-apparatet over flere uker. Denne studien vurderer endringer i dentale, alveolære, skjelettmessige og muskelske strukturer ved bruk av avansert bildebehandling som 3D Cone Beam Computed Tomography (CBCT) og overflateelektromyografi (sEMG). I tillegg vil pasientrapporterte smerte- og ubehagsnivåer bli evaluert under den ortodontiske behandlingen.
Denne studien fokuserer på å måle morfologiske og funksjonelle endringer objektivt for å fastslå om magnesiuminntak forsterker effektene av Alt-RAMEC-behandlingen og forbedrer pasientkomfort og behandlingsresultater. Funnene kan gi verdifullt bevis for å optimalisere behandlingsprotokoller for tverrgående maksillær defisiens hos unge voksne pasienter.
Studietype
Intervensjonell
Registrering (Faktiske)
38
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
Inklusjonskriterier
- Alle deltakere var unge voksne, fra aldersgruppen 18-25 år (menn eller kvinner).
- Det er en maksillær skjelettmangel hos hver pasient. (Anteroposterior mangel, bilateral/unilateral transversal mangel)
- Alle tenner har vokst ut uten unormal form eller størrelse.
- God oral hygiene og ikke-røykende vaner.
Eksklusjonskriterier:
- Tidligere ortodontisk behandling eller maksillarutvidelse
- Pasienter med alvorlig progressiv parodontal sykdom
- Pasienter med alvorlige kraniomaksillofaciale deformiteter som leppe- og ganespalte
- Midtpalatal fusjon uten vellykket utvidelse
- Første molar fraværende eller impaktiert hos pasienten
- Pasienter som har beintap, gingivtilbakegang, eller vedvarende gingival inflammasjon
- Personer med sterk brekrefleks
- Historie med livstruende medisinsk tilstand, som diabetes mellitus, eller kronisk sykdom som organtransplantatavstøtning eller kreft hos pasienter som mottar kjemoterapi eller stråleterapi og høy risiko for infeksjoner
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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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Eksperimentell: 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 navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Studer hoveddatoer
Studiestart (Faktiske)
21. januar 2025
Primær fullføring (Faktiske)
31. desember 2025
Studiet fullført (Faktiske)
31. desember 2025
Datoer for studieregistrering
Først innsendt
30. november 2025
Først innsendt som oppfylte QC-kriteriene
19. desember 2025
Først lagt ut (Faktiske)
30. desember 2025
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- USM/JEPeM/KK/24070610
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Individuelle deltakerdata (IPD) vil ikke deles utenfor forskningsteamet på grunn av bekymringer knyttet til beskyttelse av pasientkonfidensialitet og personvern.
Dataene inneholder sensitiv helseinformasjon, og deling av dem kan innebære risikoer til tross for avidentifiseringsarbeid.
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Denne begrensningen sikrer overholdelse av institusjonelle, etiske og juridiske standarder som regulerer deltakerdatasikkerhet.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .