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Efficacy of Minimally Invasive Surgical Technique in Accelerating Orthodontic Treatment

8 juin 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Description détaillée

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 .

Type d'étude

Interventionnel

Inscription (Réel)

36

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Damascus, République arabe syrienne, DM20AM18
        • Department of Orthodontics, University of Damascus Dental School

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

14 ans à 27 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Corticotomy cuts will be performed by this technique.
Expérimental: 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.
Corticotomy cuts will be performed by this technique.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Rate of canine retraction
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Rate of molar anchorage loss
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Alaa Alfawal, DDS, MSc student at the Orthodontic Department, University of Damascus Dental School
  • Chaise d'étude: Mohammad Y Hajeer, DDS MSc PhD, Associate Professor of Orthodontics, University of Damascus Dental School

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2015

Achèvement primaire (Réel)

1 avril 2016

Achèvement de l'étude (Réel)

1 juin 2016

Dates d'inscription aux études

Première soumission

11 novembre 2015

Première soumission répondant aux critères de contrôle qualité

16 novembre 2015

Première publication (Estimation)

17 novembre 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

10 juin 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 juin 2016

Dernière vérification

1 juin 2016

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • UDDS-Ortho-03-2015

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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