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Effectiveness of Two Skeletally Anchored Force Mechanics for Skeletal Class II Correction in Growing Patients

25. juli 2022 opdateret af: Yasmine Mohamed Sayed Mahmoud, Alexandria University

Effectiveness of Two Skeletally Anchored Force Mechanics for Correction of Skeletal Class II Malocclusion in Growing Patients (A Randomized Controlled Clinical Trial)

Patients with skeletal Class II malocclusion due to mandibular retrognathism will be recruited and randomly allocated to three equal groups. first group will be treated by pushing orthopedic force mechanics, second group will be treated by pulling orthopedic force mechanics, and third group will be observed for 9 months to detect the natural growth changes. Skeletal changes will be evaluated and the treatment changes will be compared with the natural growth changes. The study hypothesis is that use of direct bimaxillary miniplate anchorage in conjunction with fixed functional appliance (pushing orthopedic force) or closed coil spring (pulling orthopedic force) will induce statistically significant skeletal mandibular growth in comparison to natural mandibular growth changes.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A randomized controlled clinical trial will be conducted to address the aim of the study. Thirty-nine growing patients with skeletal Class II malocclusion due to mandibular retrognathism will be recruited. The sample will be randomly allocated to three equal groups, each including thirteen subjects. Group A will be treated by pushing orthopedic force mechanics using fixed functional appliance (Sabbagh Advanced Repositioning Appliance) anchored to four miniplates (two miniplates inserted in the mandibular symphysis and two infrazygomatic miniplates), and Group B, will be treated by pulling orthopedic force mechanics using Class II springs (CS Class II correction device) anchored to four miniplates (two inserted in the mandibular posterior buccal segment and two inserted in the maxillary anterior segment). In both groups, the appliances will be removed after reaching an edge-to-edge incisor relationship or after 9 months, whichever happens first. A similar third group (Group C) will be observed for 9 months to detect the natural growth changes. Skeletal changes will be evaluated using pretreatment and posttreatment cone beam computed tomography scans (CBCT). The treatment changes will be compared with the natural growth changes observed in group C. Other variables will be also examined including, the dentoalveolar effects, the soft tissue profile, and the patient's acceptance to this treatment modality.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

39

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Egypten
      • Alexandria, Egypten, 21526
        • Faculty of Dentistry

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

11 år til 13 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Chronological age ranges from 11 years to 13 years.
  • Skeletal Class II malocclusion with a deficient mandible (SNB ≤ 76°).
  • Horizontal growth pattern (MP/SN ≤ 39°).
  • Angle Class II division 1 malocclusion with at least 5 mm overjet.
  • Mandibular arch crowding less than 5 mm.
  • The patients have to be in the prepubertal growth stage (cervical maturational stage 3 or 4) when applying orthopedic force.
  • Patients with good oral hygiene, and a healthy periodontal condition.

Exclusion Criteria:

  • Patients who underwent previous orthodontic treatment.
  • Patients with previous craniofacial surgeries, chronic diseases, syndromes, or growth problems that may affect bone.
  • Any signs or symptoms of para-functional habits or previous history of temporomandibular disorders.
  • Extracted or missing upper permanent teeth (except for third molars).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Miniplates in mandibular symphysis & infrazygomatic
Procedure: Miniplates in mandibular symphysis & infrazygomatic
Fixed functional appliance (pushing orthopedic force) in conjunction with direct skeletal anchorage
Aktiv komparator: Miniplates in external oblique ridge & anterior maxillary region
Procedure: Miniplates in external oblique ridge & anterior maxillary region
Coil spring (pulling orthopedic force) in conjunction with direct skeletal anchorage
Ingen indgriben: Growing skeletal Class II subjects

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
change in the effective mandibular length (Co-Gn)
Tidsramme: at baseline and after treatment completion about 9 months
Correction of the skeletal Class II relation. This outcome will be detected by measuring the mean change in the effective mandibular length (Co-Gn) and position on CBCT images from baseline data (T1) and after appliance removal (T2) and will be compared with the growth changes observed in the control group
at baseline and after treatment completion about 9 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
change in maxillary length (Co-A)
Tidsramme: at baseline and after treatment completion about 9 months
The effective maxillary length (Co-A) and position changes will be measured after and chin will be measured.
at baseline and after treatment completion about 9 months
Changes in the soft tissue angle of convexity
Tidsramme: at baseline and after treatment completion about 9 months
the position of the upper and lower lips, and chin will be measured.
at baseline and after treatment completion about 9 months
patient acceptance of treatment
Tidsramme: After treatment completion about 9 months
The patient's acceptance to the treatment will be evaluated using a visual analog scale questionnaire after removal of the appliances.
After treatment completion about 9 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alexandria University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. marts 2021

Primær færdiggørelse (Forventet)

1. december 2022

Studieafslutning (Forventet)

1. december 2022

Datoer for studieregistrering

Først indsendt

24. april 2021

Først indsendt, der opfyldte QC-kriterier

10. maj 2021

Først opslået (Faktiske)

12. maj 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. juli 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juli 2022

Sidst verificeret

1. juli 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Anchored force mechanices

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