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

Primary Purpose

Class II Div 1 Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Piezocision Surgery
Sponsored by
Jordan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Class II Div 1 Malocclusion focused on measuring Canine retraction, Space closure, Rate of tooth movement, Facial divergence, Piezocision

Eligibility Criteria

15 Years - 29 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Postgraduate orthodontic clinics, Jordan University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Piezocision on high facial divergence

High facial divergence

Piezocision on average facial divergence

Average facial divergence

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 14, 2019
Last Updated
February 12, 2021
Sponsor
Jordan University of Science and Technology
Collaborators
University of Edinburgh, University of Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT04202016
Brief Title
The Rate of Space Closure With Piezocision-based Corticotomy in Different Facial Types: A Split-mouth Design
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jordan University of Science and Technology
Collaborators
University of Edinburgh, University of Sydney

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Div 1 Malocclusion
Keywords
Canine retraction, Space closure, Rate of tooth movement, Facial divergence, Piezocision

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care ProviderInvestigatorOutcomes Assessor
Masking Description
A third party will have the randomization of which side to be chosen for each case. An IT student will be asked to prepare randomized two lists using excel Microsoft program. Each list was defined based on facial divergence type; adult high, and adult average lists in the Excel columns. Underneath each list, the raws, equal number of R(right) and L(left) letters will be generated randomly. The orthodontic department's receptionist will receive the excel file, and based on which, prepare closed envelops that will be numbered. Each of which will contain a piece of paper having a letter, either R or L accordingly. The envelops will be dark and difficult to see through even under light. The periodontist will open the envelope of each patient only prior to their piezocision surgery without the involvement of the orthodontist.
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Piezocision on high facial divergence
Arm Type
Experimental
Arm Description
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.
Arm Title
High facial divergence
Arm Type
No Intervention
Arm Description
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.
Arm Title
Piezocision on average facial divergence
Arm Type
Experimental
Arm Description
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.
Arm Title
Average facial divergence
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Piezocision Surgery
Intervention Description
After a surgical cut using #15 surgical blade 2-3 mm distal to the canine a pizocision using piezo-surgery device is made.
Primary Outcome Measure Information:
Title
Rate of space closure
Description
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.
Time Frame
four and half months
Secondary Outcome Measure Information:
Title
Root resorption
Description
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.
Time Frame
Ten weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazem S. Alnimri, Professor
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Postgraduate orthodontic clinics, Jordan University of Science and Technology
City
Irbid
ZIP/Postal Code
21110
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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