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Fixed Versus Conventional Twin Block Appliances for Skeletal Class II Malocclusion

30. juni 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

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

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

  • Barn

Tager imod sunde 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

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: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Fixed twin block group
Patients treated with a fixed (bonded) Twin Block appliance for correction of skeletal Class II malocclusion due to mandibular retrognathia.
Enhed: 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
Enhed: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

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

Sponsor

Al-Azhar 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. november 2023

Primær færdiggørelse (Faktiske)

23. december 2025

Studieafslutning (Faktiske)

24. december 2025

Datoer for studieregistrering

Først indsendt

30. juni 2026

Først indsendt, der opfyldte QC-kriterier

30. juni 2026

Først opslået (Faktiske)

7. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AzharOrtho-TwinBlock-25

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Mandibular Retrognathia

Kliniske forsøg med Conventional Twin Block Appliance

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