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Completed

NCT Number: NCT03659188

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

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.

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Key information

Conditions

Malocclusion, Angle Class II, Division 1 Malocclusion Malocclusion, Angle Class II Stomatognathic Diseases Tooth Diseases

Age range

18 year–27 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthodontic Department, University of Damascus Dental School

Damascus, DM20AM18, Syria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18-27 years
  • Patients who have malocclusion class II type I and who require first-premolar extraction with:
  • Dentoalveolar class II type I with ANB between 5 and 9 degrees.
  • 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 the maxilla
  • All patients should have normal periodontal tissue and good oral health, which will be assessed by:
  • Depth of the gingival pocket does not exceed 4 mm
  • Plaque index does not exceed 1
  • 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 of their teeth since birth or who have one of the permanent teeth extracted (except the third molar)
  • Patients who have bad oral health or active periodontal disease

Treatment and study plan

Cortico-alveolar perforations

Procedure

Mechanical drills will be used on a handpiece

Other names: Flapless corticotomy

Traditional Corticotomy

Procedure

Piezo-surgery will be employed following flaps' elevation.

Primary outcomes

  1. Change in Canine Retraction Speed

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation of the Efficiency and Efficacy of Flapless Cortico-alveolar Perforations Using Mechanical Drills Versus Traditional Corticotomy in the Retraction of Upper Canines: a Three-arm Randomized Controlled Clinical Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 6, 2018
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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