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

NCT03659188 | Completed DMC

• 1 other identifier: UDDS-Ortho-18-2018
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion, Angle Class II, Division 1

Outcome Measures

Primary Outcomes (4)

• Change in Canine Retraction Speed

  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: 1. Drawing a projection from the upper canine apex to the middle palatal bone line. 2. Drawing a projection from the mesial ending of the third palatal rugae to the middle palatal bone line. 3. Measuring the distance (mm) between the two orthogonal projections. 4. The rate of canine retraction will be measured by dividing the distance between the two orthogonal projections by the time elapsed between assessment times.

  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

• Change in Anchorage Loss

  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.

  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

• Change in Canine Rotation

  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.

  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

• Change in Canine Axis

  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.

  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).

Study Arms (3)

Cortico-alveolar perforations

EXPERIMENTAL

Patients will undergo orthodontic treatment plus cortico-alveolar perforations.

Procedure: Cortico-alveolar perforations

Traditional Corticotomy

EXPERIMENTAL

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

Procedure: Traditional Corticotomy

Control

NO INTERVENTION

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

Interventions

Cortico-alveolar perforations PROCEDURE

Mechanical drills will be used on a handpiece

Also known as: Flapless corticotomy

Cortico-alveolar perforations

Traditional Corticotomy PROCEDURE

Piezo-surgery will be employed following flaps' elevation.

Traditional Corticotomy

Eligibility Criteria

• Age: 18 Years - 27 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Orthodontic Department, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related Publications (5)

• Abbas NH, Sabet NE, Hassan IT. Evaluation of corticotomy-facilitated orthodontics and piezocision in rapid canine retraction. Am J Orthod Dentofacial Orthop. 2016 Apr;149(4):473-80. doi: 10.1016/j.ajodo.2015.09.029.

  PMID: 27021451 BACKGROUND

• Alfawal AM, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Effectiveness of minimally invasive surgical procedures in the acceleration of tooth movement: a systematic review and meta-analysis. Prog Orthod. 2016 Dec;17(1):33. doi: 10.1186/s40510-016-0146-9. Epub 2016 Oct 24.

  PMID: 27696311 BACKGROUND

• Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.

  PMID: 24182579 BACKGROUND

• Aksakalli S, Calik B, Kara B, Ezirganli S. Accelerated tooth movement with piezocision and its periodontal-transversal effects in patients with Class II malocclusion. Angle Orthod. 2016 Jan;86(1):59-65. doi: 10.2319/012215-49.1. Epub 2015 May 19.

  PMID: 25989211 BACKGROUND

• Buyuk SK, Yavuz MC, Genc E, Sunar O. A novel method to accelerate orthodontic tooth movement. Saudi Med J. 2018 Feb;39(2):203-208. doi: 10.15537/smj.2018.2.21235.

  PMID: 29436571 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mohammad Al-Bitar, DDS MSc

  MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: September 6, 2018
• Study Start: September 2, 2018
• Primary Completion: October 15, 2019
• Study Completion: August 12, 2020
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)