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Posterior Resin Bite Turbos Effect on Maxillary Expansion Using a HYRAX Expander in Early Adolescents (HYRAX_ RME_SME)

13. august 2026 oppdatert av: Mansoura University

Effect of Posterior Disarticulatory Resin Bite Turbos on the Rate of Maxillary Expansion Using HYRAX Expander in Early Adolescent Patients: Randomized Controlled Clinical Trial

This randomized controlled clinical trial aims to evaluate the effect of posterior disarticulatory resin bite turbos on the rate of maxillary expansion using a HYRAX expander in early adolescent patients. Participants will be randomly assigned to receive either maxillary expansion with posterior resin bite turbos or conventional expansion without bite turbos. The study will assess and compare the rate and effectiveness of maxillary expansion between the two groups during the treatment period. Clinical measurements will be recorded to evaluate skeletal and dental changes associated with the intervention.

Studieoversikt

Detaljert beskrivelse

This study is conducted as part of a Master's thesis in Orthodontics and aims to investigate the influence of posterior disarticulatory resin bite turbos on the rate of maxillary expansion achieved using a HYRAX expander in early adolescent patients.

The study evaluates whether modifying occlusal contacts can affect skeletal and dental responses during rapid maxillary expansion.

Participants will be monitored clinically throughout the expansion phase.

Participants will be assigned in two groups:

group 1: with posterior bite turbos group 2: without posterior bite turbos

Digital intraoral scans will be taken on a weekly basis to assess changes in maxillary dimensions and to accurately measure the rate and pattern of expansion over time.

These serial digital records provide high-resolution, non-invasive documentation of treatment progress.

CBCT will be taken before the expansion and after retention phase for skeletal and dental measurement .

Studietype

Intervensjonell

Registrering (Antatt)

22

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

      • Al Mansurah, Egypt
        • Rekruttering
        • Orthodontic Department - Faculty of Dentistry Mansoura University
        • Ta kontakt med:

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

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. Patients aged 10-14 years.
  2. Bilateral posterior cross bite.
  3. Functional lateral cross bite.
  4. Good general and oral health.
  5. Normal to decreased vertical height )average FMA 29.7 °± 4.2 °).23

Exclusion Criteria:

  1. Patients with cleft lip and palate.
  2. Severe facial asymmetry.
  3. Anterior open bite.
  4. Systemic conditions affecting tooth movement (e.g., diabetes, bone disorders).
  5. Previous orthodontic treatment.

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: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: group 1: HYRAX with posterior bite turbos
Participants in this arm receive a HYRAX rapid maxillary expansion appliance combined with posterior disarticulatory resin bite turbos. The bite turbos are placed on posterior teeth to achieve occlusal disclusion, aiming to minimize occlusal interference during expansion and potentially enhance skeletal response. The HYRAX expander is activated according to a standardized protocol throughout the treatment period, with regular follow-up using clinical assessment and weekly intraoral scans.

Description:

Arm 1:

Participants in this group receive a HYRAX rapid maxillary expansion appliance combined with posterior disarticulatory resin bite turbos. The bite turbos are placed on the posterior teeth to disclude the occlusion, aiming to reduce occlusal interference and potentially enhance skeletal response during maxillary expansion. The HYRAX appliance is activated according to a standardized expansion protocol.

Aktiv komparator: Group 2 : Expansion without posterior bite turbos
Participants in this arm receive a HYRAX rapid maxillary expansion appliance without the use of posterior disarticulatory resin bite turbos. The appliance is activated according to a standardized expansion protocol similar to the experimental group. Patients are followed throughout the treatment period with regular clinical assessments and weekly intraoral scans to monitor changes in maxillary dimensions.
Participants in this group receive a HYRAX rapid maxillary expansion appliance alone without the use of posterior bite turbos. The appliance is activated following the same standardized expansion protocol as the intervention group.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The effect of occlusal disarticulation on the rate of maxillary expansion by linear measurements made on digital models
Tidsramme: Baseline and weekly during the active phase of expansion and after 3 months of retention

Dental landmarks and measurements on models :

d3 :Canine tip. d4: Central fissure of first premolar. d6 :Central fissure of first permanent molar. d_3( inter canine width): Distance between left and right d3. d_4 (inter first premolar width) : Distance between left and right d4.

d_6(inter first molar width): Distance between left and right d6.

Baseline and weekly during the active phase of expansion and after 3 months of retention

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
-The effect of the posterior disarticulation on alveolar bone changes by CBCT .
Tidsramme: baseline and after three months of retention after complete active expansion
Skeletal transverse, vertical, nasal width changes and axial inclination of posterior teeth will be evaluated .
baseline and after three months of retention after complete active expansion
pain felt by the patient after activating the expansion screw
Tidsramme: first two weeks in active phase of expansion
ain will be assessed using the Visual Analogue Scale (VAS), a 100 mm line with "no pain" at the left end and "the worst unbearable pain" at the right, which corresponds to a pain score between 0 and 10. All participants will be asked to place a vertical mark indicating the level of pain on the VAS 4 h after each activation for the first two weeks in diary sheet containing the actual size of a 100mm of VAS. 25
first two weeks in active phase of expansion

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Donia Alashker, Faculty of Dentistry Mansoura University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. februar 2026

Primær fullføring (Antatt)

1. april 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

28. juli 2026

Først innsendt som oppfylte QC-kriteriene

28. juli 2026

Først lagt ut (Faktiske)

31. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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. .

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