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Efficiency of Canine Retraction Using Different Reactivation Intervals

23. Mai 2021 aktualisiert von: Yehya Mostafa, Future University in Egypt

Comparing Canine Retraction Using Two-week, Four-week, Six-week and Eight-week Reactivation Intervals

Canine retraction after 1st premolar extracion into the extraction space is a routine treatment in orthodontics. Orthodontic patients requiring first premolar extraction, canine retraction and maximum anchorage were recruited for this randomized controlled trial. A search of the literature did not indicate the ideal frequency of elastomeric chain reactivation for optimum canine retraction. The study was approved by the ethical committee. The first premolars were extracted. Elastomeric chains were used to retract the canine distally into the 1st premolar space. The optimum reactivation interval was evaluated regarding the efficiency of treatment in terms of rate of canine retraction, canine tipping and rotation, root resorption and pain at the intervals of 2, 4, 6 and 8 weeks. Three dimensional imaging, as well as digital scanning were the methods for data collection.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The canines, 2nd premolars, 1st molars and 2nd molars were bonded and banded. Leveling and alignment was achieved. After the first premolar extraction, temporary anchorage devices were inserted interradicular between 2nd premolar and 1st molar. Canine retraction was performed on a 0.016" X 0.022" stainless steel arch wire. A power arm was extended to apply the force closer to the center of resistance and achieve bodily movement. Elastomeric chains were calibrated to deliver a force of 150g and extended from the power arm to the mini screws directly. Recruited patients were randomly allocated to four groups according to the duration between the elastomeric chain reactivation. Canine reactivation intervals were 2, 4, 6, or 8 weeks. Cone beam computed tomography was performed before canine retraction and after 6 months of retraction. Digital dental casts were taken before canine retraction and monthly for 6 months.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

56

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Ägypten
      • Cairo, Ägypten, 11865
        • Rekrutierung
        • Future University in Egypt
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

13 Jahre bis 30 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Patients requiring 1st premolar extraction (e.g bimaxillary dentoalveolar protrusion)
  • Erupted full set of permanent teeth (excluding 3rd molars)

Exclusion Criteria:

  • Systemic diseases that would interfere with bone metabolism
  • Craniofacial syndromes
  • congenitally missing or extracted permanent teeth.
  • periodontally compromised patients
  • smokers
  • pregnant women
  • previous orthodontic treatment

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 2-week reactivation interval
Replacement of elastomeric chain every 2 weeks and reestablishing a 150 g force
Verfahren: Canine retraction
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.
Aktiver Komparator: 4-week reactivation interval
Replacement of elastomeric chain every 4 weeks and reestablishing a 150 g force
Verfahren: Canine retraction
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.
Experimental: 6-week reactivation interval
Replacement of elastomeric chain every 6 weeks and reestablishing a 150 g force
Verfahren: Canine retraction
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.
Experimental: 8-week reactivation interval
Replacement of elastomeric chain every 8 weeks and reestablishing a 150 g force
Verfahren: Canine retraction
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Rate of canine retraction
Zeitfenster: Baseline to 1 month
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
Baseline to 1 month
Rate of canine retraction
Zeitfenster: 1month to 2 months
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
1month to 2 months
Rate of canine retraction
Zeitfenster: 2 months to 3 months
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
2 months to 3 months
Rate of canine retraction
Zeitfenster: 3 months to 4 months
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
3 months to 4 months
Rate of canine retraction
Zeitfenster: 4 months to 5 months
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
4 months to 5 months
Rate of canine retraction
Zeitfenster: 5 months to 6 months.
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
5 months to 6 months.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Amount of canine retraction
Zeitfenster: Baseline to 6 months
The change in distance measured from the canine cusp tip to the frontal plane, in millimeters; measured on CBCT
Baseline to 6 months
Canine tipping
Zeitfenster: Baseline to 6 months
CBCT images at T0 and T1 were analyzed using Invivo 5 software. linear measurements were made from the long axis of the canines (cusp tip to root apex) to FP1 and FP2 for the upper and lower canines, respectively.
Baseline to 6 months
Canine rotation
Zeitfenster: Baseline to 6 months
The change in the angle between a line connecting the maximum mesial and distal crown convexities and FP1 and FP2, for the upper and lower canines, respectively; measured on CBCT
Baseline to 6 months
Canine root resorption
Zeitfenster: Baseline to 6 months
The change in the canine length, in millimeters, measured from cusp tip to root apex; measured on CBCT
Baseline to 6 months
First molar anchorage loss
Zeitfenster: Baseline to 6 months
The change in distance measured from the mesio-buccal cusp tip of the first molar to the frontal plane, in millimeters; measured on CBCT
Baseline to 6 months
Pain score
Zeitfenster: baseline to day 1
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
baseline to day 1
Pain score
Zeitfenster: Baseline to day 2
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Baseline to day 2
Pain score
Zeitfenster: Baseline to day 3
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Baseline to day 3
Pain score
Zeitfenster: Baseline to day 4
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Baseline to day 4
Pain score
Zeitfenster: Baseline to day 5
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Baseline to day 5
Pain score
Zeitfenster: Baseline to day 6
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Baseline to day 6
Pain score
Zeitfenster: Baseline to day 7
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Baseline to day 7
Pain score
Zeitfenster: Baseline to day 8
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Baseline to day 8
Pain score
Zeitfenster: Baseline to day 9
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Baseline to day 9
Pain score
Zeitfenster: Baseline to day 10.
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Baseline to day 10.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Future University in Egypt

Ermittler

  • Studienleiter: Yehya Mostafa, PhD, Future University in Egypt

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. April 2017

Primärer Abschluss (Voraussichtlich)

1. Juni 2022

Studienabschluss (Voraussichtlich)

1. Juni 2022

Studienanmeldedaten

Zuerst eingereicht

23. Mai 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. Mai 2021

Zuerst gepostet (Tatsächlich)

27. Mai 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

27. Mai 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. Mai 2021

Zuletzt verifiziert

1. Mai 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 20153110-8-14-2017

Plan für individuelle Teilnehmerdaten (IPD)

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Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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