Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

The Use of Corticotomy for Upper Incisors Retraction

27 juli 2018 uppdaterad av: Damascus University

Evaluation of Treatment Outcomes of Corticotomy-accelerated Upper Incisors' Retraction: A Randomized Controlled Trial

We aim to assess the treatment outcomes following upper incisors retraction accelerated by corticotomy procedure. So, we intend to randomize orthodontic patients with class II division I malocclusion into two groups: experimental group and control group. Both groups will start orthodontic treatment. Once a 0.019*0.025-inch stainless steel wire is fully engaged to the brackets, 1st premolars will be extracted. Canines will be retracted in the conventional manner. Then, the actual evaluation period starts when the upper incisors are retracted using two different methods.

Studieöversikt

Status

Avslutad

Detaljerad beskrivning

In the last three decades, the number of adult patients seeking short orthodontic treatment time has apparently increased as the conventional orthodontic treatment usually lasts for 20-24 months. Furthermore, orthodontic treatment is often associated with root resorption, bone degradation and caries development. Patients nowadays desire to end the orthodontic treatment as soon as possible due to phsycosocial reasons and to get the goals of the treatment without affecting their social life .

So many tooth movement accelerating methods have been proposed. However, the surgical approached are considered the most effective and promising methods in accelerating tooth movement. The current research aims to evaluate the efficacy of the a new proposed surgical method compared to the conventional method in upper incisors' retraction.

Studietyp

Interventionell

Inskrivning (Faktisk)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Damascus, Syrien Arabrepubliken, DM20AM18
        • Department of Orthodontics, University of Damascus Dental School

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

15 år till 27 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Adult patients 15 to 27 years , with permanent dentition , without hypodontia .
  • Overjet less than 10 mm
  • Normal or increased growth pattern (Diagnosed by Y-axis angle)
  • Mild to moderate crowding (Less than 3 mm)
  • After canines retraction , at least 3 mm space should be available distal the lateral incisors
  • Midline deviation shouldn't be more than 3 mm

Exclusion Criteria:

  • Medically contraindicated patients to oral surgery .
  • Existence of general health issue that affect orthodontic teeth movement
  • Previous orthodontic treatment
  • Mixed dentition
  • Hypodontia (Except third molars)
  • Bad oral hygiene

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Corticotomy-assisted Retraction
Corticotomy-assisted retraction will be performed in order to help in accelerating upper incisors' retraction
Using a tunneling technique, the researcher will perform the intervention in the alveolar bone surrounding the upper incisors before retraction.
Inget ingripande: Conventional Retraction
Conventional retraction will be used in this group of patients by sliding mechanisms

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Rate of retraction
Tidsram: This will be measured at the completion of the retraction procedure, and is expected to take 2 months in the experimental group and four months in the control group.
The distance that the incisors moved during retraction divided by the time required to retract the four upper incisors to their ideal positions.
This will be measured at the completion of the retraction procedure, and is expected to take 2 months in the experimental group and four months in the control group.
Time required for retraction
Tidsram: This will be measured at the completion of the retraction procedure, and is expected to be within 2 months in the accelerated group and 4 months in the control group.
The time required from the beginning of incisors' retraction till the the completion of this procedure.
This will be measured at the completion of the retraction procedure, and is expected to be within 2 months in the accelerated group and 4 months in the control group.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in the axial inclination of upper incisors
Tidsram: A radiograph will be taken at T1: one day before upper incisors' retraction and T2: one day after the completion of upper incisors' retraction. Completion of upper incisors' retraction is expected to be within 2 months in the accelerated group and 4 mo
the angle between the long axis of the upper incisor and a reference plane drawn on a later cephalometric radiograph teken at two assessment times.
A radiograph will be taken at T1: one day before upper incisors' retraction and T2: one day after the completion of upper incisors' retraction. Completion of upper incisors' retraction is expected to be within 2 months in the accelerated group and 4 mo
Anchorage loss
Tidsram: This will be measured one day following the completion of retraction of the upper four incisors using plaster study models and is expected to be within 2 months in the accelerated group and 4 months in the control group
the amount of anchorage loss (in mm), which is the distance from a perpendicular line to the midpalatal suture and extends between central fossa of both upper first molars to the third palatal rugae . These measurements are made on plaster study models.
This will be measured one day following the completion of retraction of the upper four incisors using plaster study models and is expected to be within 2 months in the accelerated group and 4 months in the control group
Root resorption
Tidsram: An panoramic image will be taken at T1: one day before the commencement of incisor retraction and T2: one day following the completion of retraction and is expected to be within 2 months in the accelerated group and 4 months in the control group
This variable is related to the amount of incisor root resorption after treatment in both groups. This is measured on a panoramic image. The amount of root resorption = the length of an incisor after retraction subtracted from the length of an incisor before retraction. Two radiogrpahs are needed.
An panoramic image will be taken at T1: one day before the commencement of incisor retraction and T2: one day following the completion of retraction and is expected to be within 2 months in the accelerated group and 4 months in the control group

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Ghaith Al Imam, DDS, MSc student in Orthodontics, University of Damascus Dental School, Damascus, Syria

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

20 augusti 2016

Primärt slutförande (Faktisk)

20 januari 2018

Avslutad studie (Faktisk)

15 april 2018

Studieregistreringsdatum

Först inskickad

9 maj 2017

Först inskickad som uppfyllde QC-kriterierna

9 maj 2017

Första postat (Faktisk)

11 maj 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 juli 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 juli 2018

Senast verifierad

1 juli 2018

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • UDDS-Ortho-02-2017

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Klass II division 1 malocklusion

Kliniska prövningar på Corticotomy-assisted Retraction

Prenumerera