Clinical trial NCT03678805: The Effect of Surgical Interventions to Assist Orthodontic Movement of Impacted Maxillary Canines
Official title: Evaluation of the Efficiency of Minimally-invasive Surgically-assisted Withdrawal of Palatally Impacted Maxillary Canines in Terms of Movement Velocity and Dento-alveolar Changes: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaction of Tooth
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Impacted canine causes many problems for patients, such as absorption and damages to the adjacent teeth roots, as well as aesthetic problems. Correction of this problem requires a lengthy time. Therefore, many methods have been suggested to accelerate the movement of impacted canines with the help of surgical procedures.


Eligibility criteria: Inclusion Criteria:

1. Palatal or Mid-alveolar impacted canine.
2. There is no previous orthodontic treatment.
3. Healthy periodontal tissues and good oral health (i.e., Plaque Index is less or equal to 1 according to Loe and Silness(1963)).
4. No consumption of any drug that may interfere with the tooth movement (Cortisone, NSAIDs, ...).
5. Mild or no crowding in the upper jaw.
6. No history of previous trauma to the maxillofacial region or surgical interventions.

Exclusion Criteria:

1. Any systemic diseases that would affect tooth movement
2. Antidepressant prevents oral surgery
3. Any congenital syndromes or cleft lip and palate cases
4. Bad oral health
5. Previous orthodontic treatment

Primary outcomes:
measure: Duration of Canine Traction
timeFrame: The required time (in days) to achieve complete alignment of the impacted canine will be calculated which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group
measure: Change in Canine Location in the Axial View
timeFrame: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
measure: Change in Canine Inclination in the Coronal View
timeFrame: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
measure: Change in the Canine Inclination in the Sagittal View
timeFrame: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
measure: Change in the 3D Canine Location
timeFrame: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
measure: Relation to adjacent teeth
timeFrame: Just one day before the beginning of treatment
measure: Change in the Absorption to the adjacent roots
timeFrame: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Orthodontics, University of Damascus Dental School
Study officials:
affiliation: PhD Student in Orthodontics, University of Damascus Dental School, Damascus
name: Mahran Mousa, 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: Omar Heshmeh, DDS MSc PhD
role: STUDY_DIRECTOR
References:
citation: Fischer TJ. Orthodontic treatment acceleration with corticotomy-assisted exposure of palatally impacted canines. Angle Orthod. 2007 May;77(3):417-20. doi: 10.2319/0003-3219(2007)077[0417:OTAWCE]2.0.CO;2.
citation: Sukh R, Singh GP, Tandon P. Interdisciplinary approach for the management of bilaterally impacted maxillary canines. Contemp Clin Dent. 2014 Oct;5(4):539-44. doi: 10.4103/0976-237X.142828.
citation: Shastri D, Nagar A, Tandon P. Alignment of palatally impacted canine with open window technique and modified K-9 spring. Contemp Clin Dent. 2014 Apr;5(2):272-4. doi: 10.4103/0976-237X.132362.
citation: Baccetti T, Leonardi M, Armi P. A randomized clinical study of two interceptive approaches to palatally displaced canines. Eur J Orthod. 2008 Aug;30(4):381-5. doi: 10.1093/ejo/cjn023. Epub 2008 Jun 3.
citation: Leonardi M, Armi P, Franchi L, Baccetti T. Two interceptive approaches to palatally displaced canines: a prospective longitudinal study. Angle Orthod. 2004 Oct;74(5):581-6. doi: 10.1043/0003-3219(2004)0742.0.CO;2.
citation: Sebaoun JD, Surmenian J, Dibart S. [Accelerated orthodontic treatment with piezocision: a mini-invasive alternative to conventional corticotomies]. Orthod Fr. 2011 Dec;82(4):311-9. doi: 10.1051/orthodfr/2011142. Epub 2011 Nov 23. French.
citation: Walker L, Enciso R, Mah J. Three-dimensional localization of maxillary canines with cone-beam computed tomography. Am J Orthod Dentofacial Orthop. 2005 Oct;128(4):418-23. doi: 10.1016/j.ajodo.2004.04.033.
citation: Smailiene D, Kavaliauskiene A, Pacauskiene I, Zasciurinskiene E, Bjerklin K. Palatally impacted maxillary canines: choice of surgical-orthodontic treatment method does not influence post-treatment periodontal status. A controlled prospective study. Eur J Orthod. 2013 Dec;35(6):803-10. doi: 10.1093/ejo/cjs102. Epub 2013 Jan 24.
citation: Alqerban A, Jacobs R, van Keirsbilck PJ, Aly M, Swinnen S, Fieuws S, Willems G. The effect of using CBCT in the diagnosis of canine impaction and its impact on the orthodontic treatment outcome. J Orthod Sci. 2014 Apr;3(2):34-40. doi: 10.4103/2278-0203.132911.