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

J

Jordan University of Science and Technology

Status

Completed

Conditions

Class II Div 1 Malocclusion

Treatments

Procedure: Piezocision Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT04202016
20190232

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

Female

Ages

15 to 29 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

23 participants in 4 patient groups

Piezocision on high facial divergence
Experimental group
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.
Treatment:
Procedure: Piezocision Surgery
High facial divergence
No Intervention group
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.
Piezocision on average facial divergence
Experimental group
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.
Treatment:
Procedure: Piezocision Surgery
Average facial divergence
No Intervention group
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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