Magnesium (Mg)-lisäravinteen ja vuorottelevan yläleukalaajennuksen ja supistuksen (Alt-RAMEC) vaikutukset potilailla, joilla on poikittainen yläleukavaje (TMD) (Mg + Alt-RAMEC)
sunnuntai 13. syyskuuta 2026 päivittänyt: IBRAHEEM RAHMA HAZIM IBRAHEEM, Universiti Sains Malaysia
Magnesium (Mg) -lisäravinteen ja vuorottelevan yläleuan laajennuksen ja supistuksen (Alt-RAMEC) vaikutukset potilailla, joilla on poikittainen yläleukavaje (TMD): Satunnaistettu kliininen tutkimus.
Tässä satunnaistetussa kliinisessä tutkimuksessa arvioidaan magnesiumlisäyksen yhdistämisen vaikutusta ortodontiseen tekniikkaan nimeltä Vaihtoehtoinen yläleukalaajennus ja supistus (Alt-RAMEC), jossa käytetään Mikroimplantilla avustettua nopeaa kitalaulaajennusta (MARPE) laitetta aikuisten (18-30 vuotta) hoidossa, joilla on poikittainen yläleukanpuutos (TMD). TMD on tila, jossa yläleuka on kapeampi kuin normaalisti, mikä voi vaikuttaa purentaan ja kasvojen kehitykseen.
Tutkimus sisältää kaksi ryhmää: yksi saa Alt-RAMEC-protokollaa MARPE-laitteen kanssa yksinään, ja toinen saa saman protokollan yhdessä suun kautta annettujen magnesiumlisäysten kanssa. Näiden hoitojen tehokkuutta verrataan arvioimalla muutoksia hampaiden ja luuston rakenteissa kuvantamistekniikoilla ja arvioimalla lihastoimintaa. Osallistujat raportoivat myös kivun ja epämukavuuden tasoistaan hoidon aikana.
Tämän tutkimuksen tavoitteena on ymmärtää, voiko magnesiumlisäys parantaa Alt-RAMEC-hoidon vaikutuksia, parantaa potilaan tuloksia ja vähentää ortodontisten toimenpiteiden aiheuttamaa epämukavuutta.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Yksityiskohtainen kuvaus
Tämä kliininen tutkimus pyrkii arvioimaan magnesiumlisäyksen tehokkuutta yhdistettynä vaihtoehtoiseen maksillaarilaajennus- ja supistusprotokollaan (Alt-RAMEC) käyttäen mikroimplanttiavusteista nopeaa kitalaulaajennusta (MARPE) aikuisilla potilailla, joilla on poikittainen maksillaaripuutos (TMD). Tutkimus vertailee kahta hoitoryhmää: toinen ryhmä saa Alt-RAMEC-protokollaa MARPE-laitteistolla yksin, ja toinen ryhmä saa Alt-RAMEC-protokollaa MARPE-laitteiston kanssa yhdessä suun kautta annettavan magnesiumlisäyksen kanssa.
Alt-RAMEC-protokolla sisältää ohjatut maksillaarilaajennus- ja supistussyklejä maksillaaristen poikittaisten epäsuhtaisten korjaamisen helpottamiseksi. Potilaat hoidetaan tiettyjen aktivointi- ja deaktivointiregimien avulla, joissa käytetään MARPE-laitteistoa useiden viikkojen ajan. Tämä tutkimus arvioi hampaiden, alveolin, luuston ja lihasrakenteiden muutoksia käyttämällä kehittynyttä kuvantamista, kuten 3D-kartiopalkkitietokonetomografiaa (CBCT) ja pintaelektromyografiaa (sEMG). Lisäksi potilaan raportoimat kipu- ja epämukavuustasot arvioidaan ortodontisen hoidon aikana.
Tämä koe keskittyy objektiivisesti mittaamaan morfologisia ja toiminnallisia muutoksia selvittääkseen, parantaako magnesiumin saanti Alt-RAMEC-hoidon vaikutuksia ja potilaan mukavuutta sekä hoitotuloksia. Tulokset saattavat tarjota arvokasta näyttöä poikittaisen maksillaaripuutoksen hoitoprotokollien optimoinnille nuorilla aikuispotilailla.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
38
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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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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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
Osallistumiskriteerit:
Osallistumiskriteerit
- Kaikki osallistujat olivat nuoria aikuisia, 18–25-vuotiaita (miehiä tai naisia).
- Jokaisella potilaalla on yläleuan luustollinen puute (etutakainen puute, poikittainen kaksipuolinen/yksipuolinen puute).
- Kaikki hampaat olivat puhjenneet ilman poikkeavuuksia muodossa ja koossa.
- Hyvä suuhygienia ja tupakoimattomuus.
Poissulkemiskriteerit:
- Aikaisempi ortodontinen hoito tai yläleukalaajennus
- Potilaat, joilla on vaikea etenevä parodontiitti
- Potilaat, joilla on vaikeita kraniomaksillofaskiaalisia epämuodostumia, kuten huu- ja suulakihalkio
- Keskikitaluun sulautuminen ilman onnistunutta laajennusta
- Potilaalla puuttuu ensimmäinen poskihammas tai se on puhkeamatta
- Potilaat, joilla on luukatoa, ikenien vetäytymistä tai jatkuvaa ikenentulehdusta
- Henkilöt, joilla on voimakas oksennusrefleksi
- Elämää uhkaavan sairauden, kuten diabetes mellitusin, tai kroonisen sairauden, kuten elinsiirron hyljintä tai syöpä potilailla, jotka saavat kemoterapiaa tai sädehoitoa ja joilla on korkea infektioriski
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Active Comparator: 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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Kokeellinen: 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.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change from Baseline in Anterior Midpalatal Suture Separation at 12 Weeks
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Change from Baseline in Posterior Midpalatal Suture Separation at 12 Weeks
Aikaikkuna: 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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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Change from Baseline in Interzygomatic Width at 12 Weeks
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
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Perjantai 19. joulukuuta 2025
Ensimmäinen Lähetetty (Todellinen)
Tiistai 30. joulukuuta 2025
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Keskiviikko 16. syyskuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Sunnuntai 13. syyskuuta 2026
Viimeksi vahvistettu
Tiistai 1. syyskuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- USM/JEPeM/KK/24070610
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
IPD-suunnitelman kuvaus
Henkilökohtaista osallistujatietoa (IPD) ei jaeta tutkimusryhmän ulkopuolelle potilaiden luottamuksellisuuden ja yksityisyyden suojelemiseen liittyvien huolenaiheiden vuoksi.
Tiedot sisältävät arkaluonteista terveystietoa, ja niiden jakaminen voi aiheuttaa riskejä huolimatta tunnistetietojen poistamisesta.
Lisäksi tietojen jakaminen on eettisten hyväksymisten ja sopimusten alaista, jotka rajoittavat levittämistä osallistujien oikeuksien turvaamiseksi.
Tämä rajoitus varmistaa sen, että noudatetaan osallistujatietojen turvallisuutta sääteleviä instituution, eettisiä ja oikeudellisia standardeja.
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .