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

Class II Div 1 Malocclusion Clinical Trial

— RCT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04202016
• Other study ID #: 20190232
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2021
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Class II Div 1 Malocclusion
• Malocclusion

Intervention

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.

Locations

Country	Name	City	State
Jordan	Postgraduate orthodontic clinics, Jordan University of Science and Technology	Irbid

Sponsors (3)

Lead Sponsor	Collaborator
Jordan University of Science and Technology	University of Edinburgh, University of Sydney

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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