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Effects of Three Orthodontic Archwire Protocols on Root and Bone Changes

3 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

53

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
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.
Sperimentale: 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
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.
Comparatore attivo: 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.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Volumetric External Root Resorption (VERR)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Buccal Alveolar Bone Height Change (DBH)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Waseem M Allouch, DDS, MSc, Faculty of Dentistry, University of Damascus.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

3 marzo 2024

Completamento primario (Effettivo)

16 giugno 2025

Completamento dello studio (Effettivo)

25 dicembre 2025

Date di iscrizione allo studio

Primo inviato

15 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 luglio 2026

Primo Inserito (Effettivo)

7 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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