The Rate of Space Closure With Piezocision-based Corticotomy in Different Facial Types: A Split-mouth Design

Study Overview
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Brief Summary
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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.

Official Title
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Three Dimensional Analysis of the Rate of Space Closure With Piezocision-based Corticotomy in Different Facial Types: A Split-mouth Design Randomized Controlled Trial

Conditions
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Class II Div 1 Malocclusion

Intervention / Treatment
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* Procedure: Piezocision Surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Piezocision on high facial divergence<br>Piezocision Surgery prior to space closure with closing coil spring four months after extraction. Six weeks later, three other follow up appointments, six weeks apart, taking impressions to measure the rate of space closure. | Procedure: Piezocision Surgery<br>* After a surgical cut using #15 surgical blade 2-3 mm distal to the canine a pizocision using piezo-surgery device is made.<br>|
| No Intervention: High facial divergence<br>Space closure with coil spring four months after extraction. Six weeks later, three other follow up appointments, six weeks apart, taking impressions to measure the rate of space closure. | |
| Experimental: Piezocision on average facial divergence<br>Piezocision Surgery prior to space closure with closing coil spring four months after extraction. Six weeks later, three follow up appointments, six weeks apart, taking impressions to measure the rate of space closure. | Procedure: Piezocision Surgery<br>* After a surgical cut using #15 surgical blade 2-3 mm distal to the canine a pizocision using piezo-surgery device is made.<br>|
| No Intervention: Average facial divergence<br>Space closure with coil spring four months after extraction. Six weeks later, three other follow up appointments, six weeks apart, taking impressions to measure the rate of space closure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of space closure | Every six weeks from the first impression, made on the day of surgery (T0), an impression will be taken, (T1, T2, T3). Images of the impressions will be generated using computer-aided design and computer-aided manufacturing (CADCAM) to evaluate the space changes from a fixed reference point; the rugae area. | four and half months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Root resorption | The extraction will take place 10 weeks after the bonding up-appointment. Atraumatic extraction of the upper first premolars will be executed. The periodontist, performing the extraction, will have the extracted teeth stored in containers that contain sterilized deionized water. Each tooth will be placed in ultrasonic bath for 10 minutes to loosen any residual periodontal ligament's and soft tissue fragments' traces which will be later removed by wet gauze with a rubbing motion. Each tooth will be scanned three dimensionally by a desktop X-ray micro-tomography system. Teeth will be scanned with X-rays while being rotated over 360°. Three-dimension object will be generated by a 3D cone beam reconstruction algorithm utilizing the 2D images that have resulted from the scanning process. | Ten weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Canine retraction, Space closure, Rate of tooth movement, Facial divergence, Piezocision