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Direct vs Indirect In-House Clear Aligners vs Fixed Appliances in Orthodontic Treatment

4. juli 2026 opdateret af: Ahmet Yağcı, TC Erciyes University

Comparison Of Efficiency And Treatment Duration Between Clear Aligners Manufactured Directly And Indirectly By The Clinician And Fixed Orthodontic Treatment: An In Vivo Randomized Clinical Trial

Clear aligner therapy has become increasingly popular as an esthetic alternative to conventional braces in orthodontic treatment. While clear aligners are traditionally manufactured by commercial laboratories using a thermoforming technique, recent advances in 3D printing technology now allow clinicians to produce aligners directly in their own clinic, either by printing the aligner itself (direct method) or by printing a model and then thermoforming the aligner over it (indirect method)." "This study compares three approaches to orthodontic treatment in patients with mild to moderate dental crowding who do not require tooth extraction: clear aligners produced directly in-house using 3D printing with a shape-memory resin, clear aligners produced indirectly in-house using a 3D-printed model and thermoforming, and conventional fixed orthodontic treatment with metal brackets and wires." "A total of 36 patients aged 12 to 30 years were randomly assigned to one of these three treatment groups, and 33 patients completed the study. Treatment quality was evaluated using the American Board of Orthodontics Objective Grading System (ABO-OGS), an objective scoring method based on dental models obtained at the end of treatment. The total duration of treatment, from the start of active treatment to its completion, was also compared among the three groups." "The findings of this study may help clinicians and patients better understand the advantages and limitations of in-house clear aligner production compared to conventional fixed appliances, particularly regarding treatment efficiency and duration.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

36

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Tyrkiet (Türkiye)
    • Melikgazi
      • Kayseri, Melikgazi, Tyrkiet (Türkiye)
        • Erciyes University, Faculty of Dentistry, Department of Orthodontics

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
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Presence of permanent dentition (no primary teeth remaining)
  • Non-extraction orthodontic treatment plan
  • Age between 12 and 30 years
  • Mild to moderate dental crowding (0-6 mm)
  • Skeletal Class I classification (ANB: 2±2°)
  • Normal vertical growth direction (Sn-GoGn: 32±6°)
  • No congenital tooth agenesis (excluding third molars)
  • No atypical tooth shapes
  • No extracted permanent teeth
  • No dental caries
  • Good oral hygiene
  • Healthy periodontal tissues

Exclusion Criteria:

  • Presence of craniofacial anomalies
  • Systemic disease or condition
  • Previous fixed orthodontic treatment
  • History of allergy to dental materials
  • History of xerostomia

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group A ( Direct - In-House)
Participants received clear aligners manufactured directly by the clinician using 3D printing with a shape-memory resin (Tera Harz TC-85, Graphy Inc., Seoul, Korea).
Enhed: Direct In-House Clear Aligners
Clear aligners fabricated directly by the clinician using a stereolithography (SLA) 3D printer (Asiga MAX UV) with a shape-memory resin (Tera Harz TC-85, Graphy Inc., Seoul, Korea). The shell of the aligner was designed digitally using Direct Aligner Designer software and printed directly, without the need for a physical model. Printed aligners were post-processed by centrifugation to remove excess resin, followed by UV light curing.
Eksperimentel: Group B ( Indirect - In-House)
Participants received clear aligners manufactured indirectly by the clinician via 3D-printed models followed by thermoforming with CA Pro+ sheets (SCHEU-DENTAL GmbH, Iserlohn, Germany).
Enhed: Indirect In-House Clear Aligners
Clear aligners fabricated indirectly by the clinician via 3D-printed dental models (Asiga MAX UV printer) followed by thermoforming using CA Pro+ sheets (0.75 x 120 mm, SCHEU-DENTAL GmbH, Iserlohn, Germany) with a pressure-forming machine (MINISTAR S). The thermoformed aligners were trimmed from the printed model after shaping.
Aktiv komparator: Group C (Fixed Orthodontic Treatment)
Participants received conventional fixed orthodontic treatment with metal brackets (AO Mini Master Roth 018).
Enhed: Fixed Orthodontic Appliances
Conventional fixed orthodontic treatment using metal brackets (AO, Mini Master Roth 018, ) bonded to the upper and lower dental arches with stainless steel archwires.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment Quality Assessed by the American Board of Orthodontics Objective Grading System (ABO-OGS)
Tidsramme: From the date of treatment initiation (attachment placement or bracket bonding) until the date of treatment completion (final day of aligner use or bracket debonding), assessed up to 13 months
Post-treatment dental models were evaluated using the ABO Objective Grading System, which scores eight criteria: tooth alignment, marginal ridge height, buccolingual inclination, overjet, occlusal contacts, occlusal relationships, interproximal contacts, and root angulation. Lower total scores indicate better treatment quality. Scores were classified as successful (<20), borderline (20-30), or unsuccessful (>30).
From the date of treatment initiation (attachment placement or bracket bonding) until the date of treatment completion (final day of aligner use or bracket debonding), assessed up to 13 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Treatment Duration
Tidsramme: From the date of treatment initiation (attachment placement or bracket bonding) until the date of treatment completion (final day of aligner use or bracket debonding), assessed up to 13 months
The total duration of treatment was calculated as the time interval between treatment initiation (aligner delivery or bracket bonding) and treatment completion (final day of aligner use or bracket debonding)
From the date of treatment initiation (attachment placement or bracket bonding) until the date of treatment completion (final day of aligner use or bracket debonding), assessed up to 13 months

Samarbejdspartnere og efterforskere

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

Sponsor

TC Erciyes University

Samarbejdspartnere

The Scientific and Technological Research Council of Turkey

Efterforskere

  • Ledende efterforsker: Ahmet Yağcı, Prof. Dr., Erciyes University, Faculty of Dentistry, Department of Orthodontics
  • Studieleder: Musa Göksu, DDS, Erciyes University, Faculty of Dentistry, Department of Orthodontics

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)

15. februar 2024

Primær færdiggørelse (Faktiske)

15. marts 2025

Studieafslutning (Faktiske)

15. marts 2025

Datoer for studieregistrering

Først indsendt

28. juni 2026

Først indsendt, der opfyldte QC-kriterier

4. juli 2026

Først opslået (Faktiske)

7. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TDH-2024-14031

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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