Effekterna av magnesiumtillskott (Mg) och alternerande maxillär expansion och konstriktion (Alt-RAMEC) hos patienter med transversell maxillär bristning (TMD) (Mg + Alt-RAMEC)
13 september 2026 uppdaterad av: IBRAHEEM RAHMA HAZIM IBRAHEEM, Universiti Sains Malaysia
Effekterna av magnesiumtillskott (Mg) och alternerande maxillär expansion och konstriktion (Alt-RAMEC) hos patienter med transversell maxillär brist (TMD): En randomiserad klinisk studie.
Denna randomiserade kliniska studie utvärderar effekten av att kombinera magnesiumtillskott med en ortodontisk teknik som kallas Alternate Maxillary Expansion and Constriction (Alt-RAMEC) med hjälp av en Micro-implant Assisted Rapid Palatal Expansion (MARPE)-apparat för att behandla vuxna (18-30 år) med transversell maxillär brist (TMD). TMD är ett tillstånd där överkäken är smalare än normalt, vilket kan påverka bett och ansiktsutveckling.
Studien involverar två grupper: en som får Alt-RAMEC-protokollet med endast MARPE, och den andra som får samma protokoll tillsammans med orala magnesiumtillskott. Effektiviteten av dessa behandlingar kommer att jämföras genom att bedöma förändringar i dentala och skelettala strukturer via bildteknik och utvärdera muskelfunktion. Deltagarna kommer också att rapportera sina smärt- och obehagsnivåer under behandlingen.
Denna forskning syftar till att förstå om magnesiumtillskott kan förbättra effekterna av Alt-RAMEC-behandlingen, förbättra patientresultat och minska obehaget som är förknippat med ortodontiska ingrepp.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
Denna kliniska studie syftar till att utvärdera effektiviteten av magnesiumtillskott kombinerat med Alternate Maxillary Expansion and Constriction (Alt-RAMEC)-protokollet med hjälp av Micro-implant Assisted Rapid Palatal Expansion (MARPE) hos vuxna patienter med transversell maxillär brist (TMD). Studien jämför två behandlingsgrupper: en som får Alt-RAMEC-protokollet med endast MARPE, och den andra som får Alt-RAMEC med MARPE tillsammans med oralt magnesiumtillskott.
Alt-RAMEC-protokollet innebär kontrollerade cykler av maxillär expansion och konstriktion för att underlätta korrigering av transversella maxillära avvikelser. Patienter behandlas med specifika aktiverings- och deaktiveringsregimer som involverar MARPE-apparaten under flera veckor. Denna studie utvärderar förändringar i dentala, alveolära, skelettala och muskulära strukturer genom att använda avancerad bildgivning såsom 3D Cone Beam Computed Tomography (CBCT) och ytelektromyografi (sEMG). Dessutom kommer patientrapporterad smärta och obehagsnivåer att utvärderas under den ortodontiska behandlingen.
Detta försök fokuserar på att objektivt mäta morfologiska och funktionella förändringar för att avgöra om magnesiumintag förstärker effekterna av Alt-RAMEC-behandlingen och förbättrar patientens komfort och behandlingsresultat. Resultaten kan ge värdefulla bevis för att optimera hanteringsprotokoll för transversell maxillär brist hos unga vuxna patienter.
Studietyp
Interventionell
Inskrivning (Faktisk)
38
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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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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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inklusionskriterier:
Inklusionskriterier
- Alla deltagare var unga vuxna, från 18-25 års åldersgrupp (män eller kvinnor).
- Det finns en maxillär skelettbrist hos varje patient. (Anteroposterior brist, tvärgående bilateral/unilateral brist)
- Alla tänder hade framträtt utan några avvikelser vad gäller form och storlek.
- God munhygien och icke-rökande vanor.
Exklusionskriterier:
- Tidigare ortodontisk behandling eller maxillär expansion
- Patienter med allvarlig progressiv parodontit
- Patienter med allvarliga kraniomaxillofaciala missbildningar som läpp- och gomspalt
- Midpalatal fusion utan framgångsrik expansion
- Första molar saknas eller är retinerad hos patienten.
- Patienter som har benförlust, gingival recession eller ihållande gingival inflammation.
- Individer med en stark kokningsreflex.
- Tidigare livshotande medicinskt tillstånd, såsom diabetes mellitus, eller kronisk sjukdom som organavstötning efter transplantation eller cancer hos patienter som får kemoterapi eller strålbehandling och hög risk för infektioner.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / 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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Experimentell: 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.
|
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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from Baseline in Anterior Midpalatal Suture Separation at 12 Weeks
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from Baseline in Posterior Midpalatal Suture Separation at 12 Weeks
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from Baseline in Interzygomatic Width at 12 Weeks
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
21 januari 2025
Primärt slutförande (Faktisk)
31 december 2025
Avslutad studie (Faktisk)
31 december 2025
Studieregistreringsdatum
Först inskickad
30 november 2025
Först inskickad som uppfyllde QC-kriterierna
19 december 2025
Första postat (Faktisk)
30 december 2025
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 september 2026
Senast verifierad
1 september 2026
Mer information
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Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- USM/JEPeM/KK/24070610
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