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Fixed Versus Conventional Twin Block Appliances for Skeletal Class II Malocclusion

30. juni 2026 oppdatert av: Omneya mohamed abo el yazeed, Al-Azhar University

Dentoskeletal and Condylar Evaluation of Skeletal Class II Malocclusion by Fixed Twinblock Appliance Versus Conventional Twin Block Appliance Cone Beam Computed Tomography Study

This study compares two types of dental appliances a fixed Twin Block appliance and a conventional (removable) Twin Block appliance used to treat a bite problem called skeletal Class II malocclusion in growing children and teenagers. In this condition, the lower jaw is positioned further back than the upper jaw. Both appliance types work by guiding the lower jaw forward during growth. The study uses 3D imaging (cone beam computed tomography, or CBCT) before and after treatment to measure how each appliance affects the bones of the jaw, the teeth, the soft tissue profile of the face, and the jaw joint (temporomandibular joint). The goal is to determine whether the fixed or the conventional version of the appliance produces better treatment outcomes.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This comparative clinical study evaluates the skeletal, dentoalveolar, soft-tissue, and condylar/temporomandibular joint (TMJ) effects of fixed versus conventional Twin Block appliances in growing patients diagnosed with skeletal Class II malocclusion due to mandibular retrognathia. Participants were allocated to receive treatment with either a fixed or a conventional (removable) Twin Block appliance. Pre-treatment and post-treatment cone beam computed tomography (CBCT) scans were obtained to assess sagittal jaw relationships, mandibular advancement, dentoalveolar changes (including overjet and overbite correction), soft-tissue profile changes, and condylar position/remodeling within the glenoid fossa, including TMJ disc space measurements. Outcomes between the two appliance groups were compared to evaluate differences in skeletal and dental effects, as well as any differences in condylar/TMJ adaptation associated with each appliance design.

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11765
        • Faculty of Dental Medicine, Al-Azhar University

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

Ja

Beskrivelse

Inclusion Criteria:

  1. Growing male patients (as judged from clinical examination and confirmed later by (CVM)
  2. Skeletal class II with retrognathic mandible.
  3. Healthy compliant and motivated patient.
  4. No Previous orthodontic treatment.
  5. No Severe facial asymmetry determined by clinical or radiographic examination.
  6. No Systemic diseases that may affect the treatment results.
  7. No tmj disorders.

Exclusion Criteria:

  1. Previous orthodontic treatment.
  2. Poor oral hygiene.
  3. Severe facial asymmetry determined by clinical or radiographic examination.
  4. Systemic disease that may affect the treatment results. 5. TMJ disorders.

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: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Fixed twin block group
Patients treated with a fixed (bonded) Twin Block appliance for correction of skeletal Class II malocclusion due to mandibular retrognathia.
Enhet: Conventional Twin Block Appliance
A removable functional appliance consisting of upper and lower acrylic occlusal bite blocks used to advance the mandible and correct skeletal class II malocclusion in growing patients
Aktiv komparator: Conventional Twin Block Group
Patients treated with a conventional (removable) twin block appliance for correction of skeletal class II malocclusion due to mandibular retrognathia
Enhet: Conventional Twin Block Appliance
A removable functional appliance consisting of upper and lower acrylic occlusal bite blocks used to advance the mandible and correct skeletal class II malocclusion in growing patients

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Sagittal Skeletal Relationship (ANB Angle)
Tidsramme: Measured at baseline (pre-treatment) and at the end of active treatment (approximately 12-18 months, based on actual treatment duration)
Measured using cone beam computed tomography (CBCT), the ANB angle reflects the anteroposterior relationship between the maxilla and mandible. Pre-treatment and post-treatment values will be compared between the fixed and conventional Twin Block appliance groups to assess skeletal correction of Class II malocclusion.
Measured at baseline (pre-treatment) and at the end of active treatment (approximately 12-18 months, based on actual treatment duration)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Sagittal Skeletal Relationship (ANB Angle)
Tidsramme: Measured at baseline (pre-treatment) and at the end of active treatment (approximately 12-18 months, based on actual treatment duration)
Measured using cone beam computed tomography (CBCT), the ANB angle reflects the anteroposterior relationship between the maxilla and mandible. Pre-treatment and post-treatment values will be compared between the fixed and conventional Twin Block appliance groups to assess skeletal correction of Class II malocclusion.
Measured at baseline (pre-treatment) and at the end of active treatment (approximately 12-18 months, based on actual treatment duration)
Change in Condylar Position and TMJ Disc Space
Tidsramme: Measured at baseline (pre-treatment) and at the end of active treatment (approximately 12-18 months, based on actual treatment duration)
Measured using cone beam computed tomography (CBCT), condylar position within the glenoid fossa will be assessed by evaluating anterior, superior, and posterior joint spaces. TMJ disc space measurements will also be recorded to evaluate condylar remodeling and adaptation. Pre-treatment and post-treatment values will be compared between the fixed and conventional Twin Block appliance groups.
Measured at baseline (pre-treatment) and at the end of active treatment (approximately 12-18 months, based on actual treatment duration)

Samarbeidspartnere og etterforskere

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Sponsor

Al-Azhar 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)

8. november 2023

Primær fullføring (Faktiske)

23. desember 2025

Studiet fullført (Faktiske)

24. desember 2025

Datoer for studieregistrering

Først innsendt

30. juni 2026

Først innsendt som oppfylte QC-kriteriene

30. juni 2026

Først lagt ut (Faktiske)

7. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AzharOrtho-TwinBlock-25

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