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Effects of Three Orthodontic Archwire Protocols on Root and Bone Changes

3. juli 2026 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

53

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

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

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:

  • 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

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: 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.
Eksperimentel: 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.
Aktiv komparator: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Volumetric External Root Resorption (VERR)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Buccal Alveolar Bone Height Change (DBH)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Waseem M Allouch, DDS, MSc, Faculty of Dentistry, University of Damascus.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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)

3. marts 2024

Primær færdiggørelse (Faktiske)

16. juni 2025

Studieafslutning (Faktiske)

25. december 2025

Datoer for studieregistrering

Først indsendt

15. juni 2026

Først indsendt, der opfyldte QC-kriterier

3. juli 2026

Først opslået (Faktiske)

7. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2026

Sidst verificeret

1. juli 2026

Mere information

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