- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04905004
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
Status
Rekruttering
Forhold
Intervensjon / Behandling
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
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Reem ElShazly, MSc
- Telefonnummer: +201114666516
- E-post: reemhazem24@gmail.com
Studer Kontakt Backup
- Navn: Rudayna El-Badawy, MSc
- Telefonnummer: +201159218899
- E-post: rudaynaelbadawy@gmail.com
Studiesteder
-
-
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Cairo, Egypt, 11865
- Rekruttering
- Future University in Egypt
-
Ta kontakt med:
- Yehya Mostafa, PhD
- E-post: yehya3d@gmail.com
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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
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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
Ytterligere relevante MeSH-vilkår
- Medfødte abnormiteter
- Muskel- og skjelettsykdommer
- Stomatognatiske sykdommer
- Tannsykdommer
- Stomatognatiske systemabnormiteter
- Kjeveabnormiteter
- Kjevesykdommer
- Kjeveanomalier
- Kraniofaciale abnormiteter
- Muskuloskeletale abnormiteter
- Underkjevesykdommer
- Maloklusjon
- Prognatisme
- Maloklusjon, vinkelklasse III
Andre studie-ID-numre
- 20153110-8-14-2017
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
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