Comparison Between Two Methods in the Acceleration of the Retraction of Upper Canines

Sponsor
Damascus University (Other)
Overall Status
Completed
CT.gov ID
NCT03659188
Collaborator
(none)
58
1
3
23.3
2.5

Study Details

Study Description

Brief Summary

Patients at the Orthodontic Department of University of Damascus Dental School will be examined and subjects who meet the inclusion criteria will be included.

Then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, as well as radiographic images) will be studied to ensure that the selection criteria are accurately matched.

The aim of this study is to compare flapless bone cutting by mechanical drills to evaluate the acceleration of the retraction of upper canines versus traditional bone cutting by piezo-surgery in comparison with a control group without bone cutting after extraction of upper first premolars in class II type I patients.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Corticotomy with drills
  • Procedure: Traditional Corticotomy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Efficiency and Efficacy of Flapless Corticotomy Using Mechanical Drills Versus Traditional Corticotomy in the Retraction of Upper Canines: a Three-arm Randomized Controlled Clinical Trial
Actual Study Start Date :
Sep 2, 2018
Actual Primary Completion Date :
Oct 15, 2019
Actual Study Completion Date :
Aug 12, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Corticotomy with drills

Patients will undergo orthodontic treatment plus an acceleration procedure employing corticotomy with drills.

Procedure: Corticotomy with drills
Mechanical drills will be used on a handpiece
Other Names:
  • Flapless corticotomy
  • Experimental: Traditional Corticotomy

    Patients will undergo orthodontic treatment plus an acceleration procedure employing traditional corticotomy.

    Procedure: Traditional Corticotomy
    Piezo-surgery will be employed following flaps' elevation.

    No Intervention: Control

    Patients will undergo orthodontic treatment in which canine retraction will be accomplished using the standard sliding mechanism without any acceleration procedures.

    Outcome Measures

    Primary Outcome Measures

    1. Change in Canine Retraction Speed [T1: At the end of alignment (which is expected within 3 months); T2: 1 month after canine retraction; T3: After two months; T4: After 3 months; T5: at the end of canine retraction which is expected within 5 months]

      The rate at which canine is going to be retracted (mm/month) in each group will be calculated. This outcome will be measured by the following steps: Drawing a projection from the upper canine apex to the middle palatal bone line. Drawing a projection from the mesial ending of the third palatal rugae to the middle palatal bone line. Measuring the distance (mm) between the two orthogonal projections. The rate of canine retraction will be measured by dividing the distance between the two orthogonal projections by the time elapsed between assessment times.

    2. Change in Anchorage Loss [T1: At the end of alignment (which is expected within 3 months); T2: 1 month after canine retraction; T3: After two months; T4: After 3 months; T5: at the end of canine retraction which is expected within 5 months]

      Anchorage loss in related the mesial drift of the first molar. This outcome will be measured by drawing two projections from the central groove of the first maxillary molar and the mesial ending of the third palatal rugae to the middle palatal bone line. The mesial migration of the first maxillary molar (mm) will be measured by dividing the distance between the two projections by the time elapsed between assessment times.

    3. Change in Canine Rotation [T1: At the end of alignment (which is expected within 3 months); T2: 1 month after canine retraction; T3: After two months; T4: After 3 months; T5: at the end of canine retraction which is expected within 5 months]

      The angle between the middle palatal bone and the line through the mesial and distal edges of the canine will be measured on each side. The rotation will be assessed by calculating the difference between the angles on two different times. Then, the speed of rotation will be calculated by dividing the rotation angle (degrees) by time that elapsed between assessment times.

    4. Change in Canine Axis [T1: at the end of the alignment stage (which is expected within 3 to 4 months); T2: at the end of the canine retraction stage (which is expected to occur with 4 to five months following the onset of this stage).]

      The changes in the canine axis during retraction will be studied by calculating canine angulation (arithmetic mean of the angulation of the right and left upper canine axis with the anterior cranial base plane) on lateral cephalometric radiographs. The difference between the canine angulation on T1 and T2 will be calculated after comparing the two cephalometric using Viewbox version 4.0.0.98.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 28 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age between 15-28 years

    • Patients who have malocclusion class II type I and who require first-premolar extraction with:

    • Dentoalveolar class II type I with ANB between (0-5)

    • Protrusion between (5-10 mm)

    • Overbite between (0-4)

    • Vertical dimension is normal or over the normal range

    • Mild to moderate crowding

    • All patients should have complete permanent occlusion on maxilla

    • All patients should have normal periodontal tissue and good oral health which will be assessed by:

    1. Depth of the gingival pocket does not exceed 4 mm

    2. Plaque index does not exceed 1

    3. Gingival index does not exceed 1

    Exclusion Criteria:
    • Patients in which oral surgery under local anesthesia is contraindicated due to medical, psychological, or social reasons.

    • Patients who have a general health problem that affects dental movement

    • Patients who have undergone previous orthodontic treatment

    • Patients with mixed occlusion

    • Patients who have lost one or more from their teeth since birth or who have one of the permanent teeth extracted (except third molar)

    • Patients who have bad oral health or active periodontal disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Orthodontic Department, University of Damascus Dental School Damascus Syrian Arab Republic DM20AM18

    Sponsors and Collaborators

    • Damascus University

    Investigators

    • Principal Investigator: Mohammad Al-Bitar, DDS MSc, MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria
    • Study Director: Mohammad Y Hajeer, DDS MSc PhD, Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
    • Study Director: Bassel Brad, DDS MSc PhD, Associate Professor of Oral and Maxillofacial Surgery, Oral and Maxillofacial Surgery Department, University of Damascus Dental School, Damascus, SYRIA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Damascus University
    ClinicalTrials.gov Identifier:
    NCT03659188
    Other Study ID Numbers:
    • UDDS-Ortho-18-2018
    First Posted:
    Sep 6, 2018
    Last Update Posted:
    Nov 20, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 20, 2020