- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04905004
Efficiency of Canine Retraction Using Different Reactivation Intervals
23. maj 2021 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
56
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Reem ElShazly, MSc
- Telefonnummer: +201114666516
- E-mail: reemhazem24@gmail.com
Undersøgelse Kontakt Backup
- Navn: Rudayna El-Badawy, MSc
- Telefonnummer: +201159218899
- E-mail: rudaynaelbadawy@gmail.com
Studiesteder
-
-
-
Cairo, Egypten, 11865
- Rekruttering
- Future University in Egypt
-
Kontakt:
- Yehya Mostafa, PhD
- E-mail: yehya3d@gmail.com
-
-
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
13 år til 30 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
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: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Yehya Mostafa, PhD, Future University in Egypt
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)
1. april 2017
Primær færdiggørelse (Forventet)
1. juni 2022
Studieafslutning (Forventet)
1. juni 2022
Datoer for studieregistrering
Først indsendt
23. maj 2021
Først indsendt, der opfyldte QC-kriterier
23. maj 2021
Først opslået (Faktiske)
27. maj 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. maj 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. maj 2021
Sidst verificeret
1. maj 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Medfødte abnormiteter
- Muskuloskeletale sygdomme
- Stomatognatiske sygdomme
- Tandsygdomme
- Stomatognatiske systemabnormiteter
- Abnormiteter i kæben
- Kæbesygdomme
- Maxillofacial abnormiteter
- Kraniofaciale abnormiteter
- Muskuloskeletale abnormiteter
- Mandibular sygdomme
- Maloklusion
- Prognathisme
- Malocclusion, vinkelklasse III
Andre undersøgelses-id-numre
- 20153110-8-14-2017
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