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

NCT04202016 | Completed

• 1 other identifier: 20190232
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Class II Div 1 Malocclusion

Keywords

Canine retraction; Space closure; Rate of tooth movement; Facial divergence; Piezocision

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Root resorption

  Ten weeks

Study Arms (4)

Piezocision on high facial divergence

EXPERIMENTAL

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

High facial divergence

NO INTERVENTION

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 on average facial divergence

EXPERIMENTAL

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

Average facial divergence

NO INTERVENTION

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.

Interventions

Piezocision Surgery PROCEDURE

After a surgical cut using #15 surgical blade 2-3 mm distal to the canine a pizocision using piezo-surgery device is made.

Piezocision on average facial divergence; Piezocision on high facial divergence

Eligibility Criteria

• Age: 15 Years - 29 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jordan University of Science and Technology: lead
• University of Edinburgh: collaborator
• University of Sydney: collaborator

Study Sites (1)

Postgraduate orthodontic clinics, Jordan University of Science and Technology

Irbid, 21110, Jordan

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Kazem S. Alnimri, Professor

  Jordan University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2019
• First Posted: December 17, 2019
• Study Start: November 1, 2018
• Primary Completion: November 30, 2020
• Study Completion: December 30, 2020
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)