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Efficiency of Canine Retraction Using Different Reactivation Intervals

23. mai 2021 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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

Intervensjonell

Registrering (Forventet)

56

Fase

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Kontakter og plasseringer

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Studiekontakt

Studer Kontakt Backup

Studiesteder

      • Cairo, Egypt, 11865
        • Rekruttering
        • Future University in Egypt
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Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

13 år til 30 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 2-week reactivation interval
Replacement of elastomeric chain every 2 weeks and reestablishing a 150 g force
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.
Aktiv komparator: 4-week reactivation interval
Replacement of elastomeric chain every 4 weeks and reestablishing a 150 g force
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.
Eksperimentell: 6-week reactivation interval
Replacement of elastomeric chain every 6 weeks and reestablishing a 150 g force
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.
Eksperimentell: 8-week reactivation interval
Replacement of elastomeric chain every 8 weeks and reestablishing a 150 g force
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rate of canine retraction
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Amount of canine retraction
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

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Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2017

Primær fullføring (Forventet)

1. juni 2022

Studiet fullført (Forventet)

1. juni 2022

Datoer for studieregistrering

Først innsendt

23. mai 2021

Først innsendt som oppfylte QC-kriteriene

23. mai 2021

Først lagt ut (Faktiske)

27. mai 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. mai 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. mai 2021

Sist bekreftet

1. mai 2021

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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