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Efficacy of Minimally Invasive Surgical Technique in Accelerating Orthodontic Treatment

8 juni 2016 bijgewerkt door: Damascus University

Evaluation the Efficacy of Flapless Corticotomy Accomplished by Either Hard-laser or Piezosurgey in Accelerating Upper Canine Retraction and Evaluation of the Dento-alveolar Changes and the Levels of Acceptance and Discomfort.

Thirty six patients needs therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines will be divided randomly into two groups : piezocision group and the ER:yttrium aluminum garnet (YAG) laser group. In each group, piezocision or hard laser-assisted flapless corticotomy will randomly assigned to one side of the maxillary arch at the first premolar region, and the other side served as the control. Canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side, soldered trans-palatal arch will be used as an anchor unit.

Pre- and post distalization dental casts will be evaluated to study rate of canine distalization, canine rotation and anchorage loss over a follow-up period until a Class I canine relationship is achieved. The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales administered at four assessment times during the first month after the minimally invasive procedure.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

One main issue in orthodontics is the prolonged treatment time, leading patients, especially adults, to avoid treatment or seek alternative options such as implants or veneers with less than optimal results.

Therefore, the search for methods that decrease the treatment duration is a main challenge in orthodontic research. Decreased duration of therapy seems to be related not only to better patient compliance, but also to reduced treatment -related root resorption , better periodontal health and lower risk of caries and white spots. Adjunct to the proper selection of brackets, wires, biomechanic systems, force levels, and anchorage systems, an array of novel techniques has been introduced to accelerate orthodontic tooth movement. These techniques can be briefly categorized as surgical and non-surgical. However The surgical approach is the most clinically used and most tested with known predictions and stable results. The invasiveness of surgical procedures, requiring full mucoperiosteal flaps, might have been a drawback for their widespread acceptance among orthodontists and patients. Therefore, more conservative flapless corticotomy techniques have recently been proposed. Although various techniques of flapless corticotomy have been reported to be successful in practice, scientific evidence for their effectiveness so far has been limited to case series and a handful of clinical trials, generally with small groups. Therefore further controlled prospective studies are needed to study the effectiveness of flapless corticotomy in accelerating orthodontic tooth movement .

Studietype

Ingrijpend

Inschrijving (Werkelijk)

36

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.

Studie Locaties

  • Syrische Arabische Republiek
      • Damascus, Syrische Arabische Republiek, DM20AM18
        • Department of Orthodontics, University of Damascus Dental School

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

14 jaar tot 27 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Adult healthy patients , Male and female , Age range: 15-27 years.

  • Class II Division 1 malocclusion :

    • Mild / moderate skeletal Class II (sagittal discrepancy angle ≤7)
    • Overjet ≤10
    • Normal or excessive facial height (Clinically and then cephalometrically assessed using these three angles : mandibular/cranial base angle, maxillary/mandibular plane angle and facial axis angle)
    • Mild to moderate crowding ≤ 4
  • Permanent occlusion.
  • Existence of all the upper teeth (except third molars).

  • Good oral and periodontal health:

    • Probing depth < 4 mm
    • No radiographic evidence of bone loss .
    • Gingival index ≤ 1
    • Plaque index ≤ 1

Exclusion Criteria:

  • Medical problems that affect tooth movement (corticosteroid, nonsteroidal antiinflammatory drugs (NSAIDs), …)
  • patients have anti indication for oral surgery ( medical - social - psycho)
  • Presence of primary teeth in the maxillary arch
  • Missing permanent maxillary teeth (except third molars).

  • Poor oral hygiene or Current periodontal disease:

    • Probing depth ≥ 4 mm
    • radiographic evidence of bone loss
    • Gingival index > 1
    • Plaque index > 1
  • Patient had 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: Piezosurgery
In one half of the dental arch, piezosurgery will be performed for canine retraction, whereas in the other half ordinary canine retraction procedure will be followed.
Procedure: Piezosurgery
Corticotomy cuts will be performed by this technique.
Experimenteel: ER:YAG Laser
In one half of the dental arch, ER:YAG laser irradiation will be performed for canine retraction, whereas in the other half ordinary canine retraction procedure will be followed.
Straling: ER:YAG laser
Corticotomy cuts will be performed by this technique.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of canine retraction
Tijdsspanne: This will be measured immediately at the end of the tooth movement, i.e. when the retracted canine reaches its final position which takes up to 12 weeks
The distance traveled by mm is divided by the time required in weeks.
This will be measured immediately at the end of the tooth movement, i.e. when the retracted canine reaches its final position which takes up to 12 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of molar anchorage loss
Tijdsspanne: This will be measured immediately at the end of the tooth movement, i.e. when the retracted canine reaches its final position which may take up to 12 weeks
The amount of mesial movement of the first molar in millimeters (mm) is divided by the time required to retract the upper canines (in weeks).
This will be measured immediately at the end of the tooth movement, i.e. when the retracted canine reaches its final position which may take up to 12 weeks
Change in canine rotation
Tijdsspanne: This will be measured at the following assessment times: T1: baseline, T2: after 4 weeks of canine retraction, T3: after 8 weeks of canine retraction, T4: when the canine reaches its final position up to 12 weeks
This measurement will be performed on plaster models taken at the aforementioned assessment times.
This will be measured at the following assessment times: T1: baseline, T2: after 4 weeks of canine retraction, T3: after 8 weeks of canine retraction, T4: when the canine reaches its final position up to 12 weeks
Change in the levels of pain and discomfort
Tijdsspanne: These levels will be assessed at: one day following the intervention, one week, two weeks, and four weeks following the intervention.
Assessment will be performed using questionnaires via visual analog scales.
These levels will be assessed at: one day following the intervention, one week, two weeks, and four weeks following the intervention.

Medewerkers en onderzoekers

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

Sponsor

Damascus University

Onderzoekers

  • Hoofdonderzoeker: Alaa Alfawal, DDS, MSc student at the Orthodontic Department, University of Damascus Dental School
  • Studie stoel: Mohammad Y Hajeer, DDS MSc PhD, Associate Professor of Orthodontics, University of Damascus Dental School

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

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

1 april 2015

Primaire voltooiing (Werkelijk)

1 april 2016

Studie voltooiing (Werkelijk)

1 juni 2016

Studieregistratiedata

Eerst ingediend

11 november 2015

Eerst ingediend dat voldeed aan de QC-criteria

16 november 2015

Eerst geplaatst (Schatting)

17 november 2015

Updates van studierecords

Laatste update geplaatst (Schatting)

10 juni 2016

Laatste update ingediend die voldeed aan QC-criteria

8 juni 2016

Laatst geverifieerd

1 juni 2016

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UDDS-Ortho-03-2015

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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