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

Malocclusion, Angle Class II, Division 1 Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03659188
• Other study ID #: UDDS-Ortho-18-2018
• Status: Completed
• Phase: N/A
• Start date: September 2, 2018
• Est. completion date: August 12, 2020

Study information

• Verified date: March 2023
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 12, 2020
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 27 Years

Eligibility

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:

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 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

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class II
• Malocclusion, Angle Class II, Division 1

Intervention

Procedure:
• Cortico-alveolar perforations
Mechanical drills will be used on a handpiece
• Traditional Corticotomy
Piezo-surgery will be employed following flaps' elevation.

Locations

Country	Name	City	State
Syrian Arab Republic	Orthodontic Department, University of Damascus Dental School	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: 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.	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
Primary	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
Primary	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
Primary	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).