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

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

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.

Study Overview

• Status: Completed
• Conditions: Class II Div 1 Malocclusion
• Intervention / Treatment: Procedure: Piezocision Surgery

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Irbid, Jordan, 21110
    • Postgraduate orthodontic clinics, Jordan University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 29 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Piezocision on high facial divergence; 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; After a surgical cut using #15 surgical blade 2-3 mm distal to the canine a pizocision using piezo-surgery device is made.
No Intervention: High facial divergence; 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; 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; After a surgical cut using #15 surgical blade 2-3 mm distal to the canine a pizocision using piezo-surgery device is made.
No Intervention: Average facial divergence; 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?

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

Collaborators and Investigators

• Sponsor: Jordan University of Science and Technology
• Collaborators: University of Edinburgh; University of Sydney
• Investigators: Study Director: Kazem S. Alnimri, Professor, Jordan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: December 14, 2019
• First Submitted That Met QC Criteria: December 14, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Canine retraction; Piezocision; Space closure; Rate of tooth movement; Facial divergence
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 20190232

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No