Clinical trial NCT03659188: Comparison Between Two Methods in the Acceleration of the Retraction of Upper Canines
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion, Angle Class II, Division 1
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Canine Retraction Speed
timeFrame: 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
measure: Change in Anchorage Loss
timeFrame: 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
measure: Change in Canine Rotation
timeFrame: 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
measure: Change in Canine Axis
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Orthodontic Department, University of Damascus Dental School
Study officials:
affiliation: MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria
name: Mohammad Al-Bitar, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
name: Mohammad Y Hajeer, DDS MSc PhD
role: STUDY_DIRECTOR
affiliation: Associate Professor of Oral and Maxillofacial Surgery, Oral and Maxillofacial Surgery Department, University of Damascus Dental School, Damascus, SYRIA
name: Bassel Brad, DDS MSc PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.
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.
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.