Clinical trial NCT04202016: The Rate of Space Closure With Piezocision-based Corticotomy in Different Facial Types: A Split-mouth Design
Official title: Three Dimensional Analysis of the Rate of Space Closure With Piezocision-based Corticotomy in Different Facial Types: A Split-mouth Design Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class II Div 1 Malocclusion
Keywords: Canine retraction
Space closure
Rate of tooth movement
Facial divergence
Piezocision
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
Collaborators: name: University of Edinburgh
name: University of Sydney
First posted: 2019-12-17
Enrollment: 23
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The design will be a split-mouth where the participants should need extraction based treatment in collateral sides of the upper arch with one of the sides serving as the treatment while the other will be the control. Then they will be grouped based on their facial type.
Primary purpose: SCREENING

Brief summary: 23 female participants with class II div I will have extraction of bilateral first bicuspids 10 weeks after bond- up appointment. The extracted teeth will be preserved in special containers for subsequent microscopic analysis. Four months later, upon space closure phase, the patient will have a piezocision surgery on one side randomly chosen. Virtual models will be generated once before the surgery and monthly after for four and a half months. The models will be scanned by CADCAM and later tooth movement will be analyzed in regards to the rugae area.


Eligibility criteria: Inclusion Criteria:

* Young adults and adults (15-29).
* Middleastern Caucasian.
* Females.
* Having the defined orthodontic appliance, slot size, prescription, and technique of space closure.
* Class II division I of moderate space requirement that is planned to have the first premolar extracted.
* Average or high facial type.
* Healthy patients without systematic diseases that could affect bone and tooth movement and no contraindication (medical or psychological) to avoid oral surgery.
* No active periodontal diseases as this effect the cytokines expression (stabilized prostaglandin (PG) health)
* Good oral hygiene.
* No other method of non-surgical acceleration technique to be used.

Exclusion Criteria:

* Patients who refused to consent for the study.
* The two extremes of age (younger than 14 and older than 29).
* Having other than the defined orthodontic appliance, slot size, prescription, and technique of space closure.
* Extraction cases of high space requirements or other teeth than the first premolar.
* Patients with systematic diseases that could affect bone and tooth movement and no contraindication (medical or psychological) avoid oral surgery.
* Active periodontal diseases.
* Other methods of non-surgical acceleration technique to be used.

Primary outcomes:
measure: Rate of space closure
timeFrame: four and half months
Secondary outcomes:
measure: Root resorption
timeFrame: Ten weeks
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Postgraduate orthodontic clinics, Jordan University of Science and Technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Kazem S. Alnimri, Professor
role: STUDY_DIRECTOR
References: