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

• ClinicalTrials.gov Identifier: NCT03659188
• Recruitment Status: Completed
• First Posted: September 6, 2018
• Last Update Posted: November 20, 2020
• Sponsor: Damascus University
• Information provided by (Responsible Party): Damascus University

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
Malocclusion, Angle Class II, Division 1	Procedure: Corticotomy with drills; Procedure: Traditional Corticotomy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: September 2, 2018
• Actual Primary Completion Date: October 15, 2019
• Actual Study Completion Date: August 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 Name: 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 [ 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:

   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.
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.

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 28 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Syrian Arab Republic

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

More Information

Publications:

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.

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. Epub 2016 Oct 24. Review.

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.

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.

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.

• Responsible Party: Damascus University
• ClinicalTrials.gov Identifier: NCT03659188
• Other Study ID Numbers: UDDS-Ortho-18-2018
• First Posted: September 6, 2018
• Last Update Posted: November 20, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• 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:

Malocclusion; Malocclusion, Angle Class II; Overbite; Tooth Diseases; Stomatognathic Diseases