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Efficiency of Canine Retraction Using Different Reactivation Intervals

23 mei 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

56

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Egypte
      • Cairo, Egypte, 11865
        • Werving
        • Future University in Egypt
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

13 jaar tot 30 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 2-week reactivation interval
Replacement of elastomeric chain every 2 weeks and reestablishing a 150 g force
Procedure: Canine retraction
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.
Actieve vergelijker: 4-week reactivation interval
Replacement of elastomeric chain every 4 weeks and reestablishing a 150 g force
Procedure: Canine retraction
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.
Experimenteel: 6-week reactivation interval
Replacement of elastomeric chain every 6 weeks and reestablishing a 150 g force
Procedure: Canine retraction
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.
Experimenteel: 8-week reactivation interval
Replacement of elastomeric chain every 8 weeks and reestablishing a 150 g force
Procedure: Canine retraction
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of canine retraction
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Amount of canine retraction
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Future University in Egypt

Onderzoekers

  • Studie directeur: Yehya Mostafa, PhD, Future University in Egypt

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 april 2017

Primaire voltooiing (Verwacht)

1 juni 2022

Studie voltooiing (Verwacht)

1 juni 2022

Studieregistratiedata

Eerst ingediend

23 mei 2021

Eerst ingediend dat voldeed aan de QC-criteria

23 mei 2021

Eerst geplaatst (Werkelijk)

27 mei 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 mei 2021

Laatste update ingediend die voldeed aan QC-criteria

23 mei 2021

Laatst geverifieerd

1 mei 2021

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 20153110-8-14-2017

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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