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Effects of Three Orthodontic Archwire Protocols on Root and Bone Changes

3. července 2026 aktualizováno: Damascus University

Three-dimensional Evaluation of Volumetric Root Resorption and Alveolar Bone Changes Following Three Orthodontic Archwire Protocols: a Randomized Controlled Clinical Trial

This randomized controlled clinical trial compares the effects of three orthodontic archwire protocols used during the alignment phase on anterior tooth roots and the supporting alveolar bone. Participants were randomly allocated to one of three parallel groups according to the experimental archwire used. Cone-beam computed tomography (CBCT) images were obtained before treatment initiation and after completion of the follow-up period. The primary outcome is volumetric root resorption, while secondary outcomes include changes in Buccal alveolar bone height and thickness. Recruitment and follow-up have been completed, and the study is currently in the data verification and statistical analysis phase. The findings are expected to help clinicians choose archwire protocols that reduce undesirable biological side effects during orthodontic treatment.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Orthodontic tooth movement may result in undesirable biological side effects, including external root resorption and remodeling of the alveolar bone surrounding the moved teeth. These effects are clinically important because they may influence long-term tooth support and treatment safety. During the alignment phase of orthodontic treatment, different archwire designs may produce different biomechanical effects; however, evidence comparing their influence on root structure and alveolar bone remains limited.

This study is a randomized controlled clinical trial designed to compare three orthodontic archwire protocols during the alignment phase in patients undergoing fixed orthodontic treatment. The primary objective is to assess volumetric root resorption in the anterior teeth using three-dimensional CBCT-based measurements. Secondary objectives include assessment of alveolar bone height change, and alveolar bone thickness change at standardized cervical, middle, and apical levels.

Participants were enrolled from the Department of Orthodontics, Faculty of Dentistry, Damascus University. Eligible patients were randomly allocated to one of three parallel groups. All groups received the same initial alignment sequence using 0.014-inch nickel-titanium and 0.016-inch nickel-titanium archwires. The groups differed in the experimental archwire used thereafter. The square group received a 0.016 × 0.016-inch nickel-titanium archwire, the rectangular group received a 0.016 × 0.022-inch nickel-titanium archwire, and the control group continued with a 0.016-inch round nickel-titanium archwire. Archwire changes were performed at standardized 35-day intervals according to the study protocol.

CBCT records were obtained at baseline before treatment initiation and again at the end of the observation period. Root volume measurements were used to calculate volumetric root resorption in cubic millimeters and as a percentage of the baseline root volume. Buccal alveolar bone height and thickness were measured on standardized CBCT sections using predefined reference planes and anatomical landmarks.

Participant recruitment started on 01 October 2023, and follow-up of the last participant was completed on 25 June 2025. The study is currently in the data verification and statistical analysis phase.

Typ studie

Intervenční

Zápis (Aktuální)

53

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Sýrie
    • Rif-dimashq Governorate
      • Damascus, Rif-dimashq Governorate, Sýrie, DM20AM19
        • Department of Orthodontics, Faculty of Dentistry, University of Damascus

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Patients aged between 16 and 25 years
  • Presence of a complete permanent dentition
  • Moderate crowding ranging from 4 to 6 mm, according to Little's Irregularity Index (Little, 1975)
  • Indication for non-extraction orthodontic treatment
  • Normal or slightly retroclined incisors, as evaluated radiographically and on study models
  • Good oral health status
  • Periodontally healthy supporting tissues

Exclusion Criteria:

  • Patients with severe skeletal discrepancies
  • Patients with craniofacial anomalies
  • Presence of impacted or supernumerary teeth
  • History of previous orthodontic treatment
  • Presence of systemic conditions or use of medications known to influence tooth movement
  • Pregnant women
  • Patients for whom the follow-up (T1) records were not obtained within the permitted 35-day window

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Square-shaped cross-sectional archwire group
Participants in this group received fixed orthodontic treatment with an alignment sequence ending with a 0.016 × 0.016-inch nickel-titanium archwire as the experimental archwire
Postup: Square-shaped cross-sectional archwire
Fixed orthodontic treatment using the following archwire sequence: 0.014-inch NiTi, followed by 0.016-inch NiTi, followed by 0.016 × 0.016-inch NiTi as the experimental archwire. Archwire change will be done at 35-day intervals.
Experimentální: Rectangular-shaped cross-sectional archwire group
Participants in this group received fixed orthodontic treatment with an alignment sequence ending with a 0.016 × 0.022-inch nickel-titanium archwire as the experimental archwire
Postup: Rectangular-shaped cross-sectional archwire
Fixed orthodontic treatment using the following archwire sequence: 0.014-inch NiTi, followed by 0.016-inch NiTi, followed by 0.016 × 0.022-inch NiTi as the experimental archwire. Archwire change will be done at 35-day intervals.
Aktivní komparátor: Control group
Participants in this group received fixed orthodontic treatment with an alignment sequence ending with a 0.016-inch round nickel-titanium archwire, which served as the control wire.
Postup: Traditional sequence of archwires
Fixed orthodontic treatment using the following archwire sequence: 0.014-inch NiTi, followed by 0.016-inch NiTi, followed by 0.016-inch round NiTi, which served as the control archwire. Archwire change will be done at 35-day intervals.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Volumetric External Root Resorption (VERR)
Časové okno: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
Volumetric root resorption was assessed in the anterior teeth using cone-beam computed tomography (CBCT) and three-dimensional volumetric analysis. Root volume was measured at baseline and follow-up, and the difference between the two measurements was recorded as volumetric root resorption. The unit of measurement was cubic millimeters (mm³).
Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Buccal Alveolar Bone Height Change (DBH)
Časové okno: Measured on CBCT images obtained at baseline before treatment initiation and at the end of six-month follow-up period.
Buccal alveolar bone height was measured as the vertical distance from a standardized horizontal reference plane to the most coronal point of the Buccal alveolar crest on CBCT images. The change between baseline and follow-up was recorded in millimeters (mm).
Measured on CBCT images obtained at baseline before treatment initiation and at the end of six-month follow-up period.
Buccal Alveolar Bone Thickness Change at the Cervical Level (DBT-CT)
Časové okno: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
Buccal alveolar bone thickness at the cervical level was measured on CBCT images using a standardized geometric protocol. The change between baseline and follow-up was recorded in millimeters (mm).
Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
Buccal Alveolar Bone Thickness Change at the Middle Level (DBT-MT)
Časové okno: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
Buccal alveolar bone thickness at the middle root level was measured on CBCT images using a standardized geometric protocol. The change between baseline and follow-up was recorded in millimeters (mm).
Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
Buccal Alveolar Bone Thickness Change at the Apical Level (DBT-AT)
Časové okno: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
Buccal alveolar bone thickness at the apical level was measured on CBCT images using a standardized geometric protocol. The change between baseline and follow-up was recorded in millimeters (mm).
Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Damascus University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Waseem M Allouch, DDS, MSc, Faculty of Dentistry, University of Damascus.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

3. března 2024

Primární dokončení (Aktuální)

16. června 2025

Dokončení studie (Aktuální)

25. prosince 2025

Termíny zápisu do studia

První předloženo

15. června 2026

První předloženo, které splnilo kritéria kontroly kvality

3. července 2026

První zveřejněno (Aktuální)

7. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

7. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • UDDS-2026-Ortho-5

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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