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Completed

NCT Number: NCT04202016

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

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.

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Key information

Conditions

Class II Div 1 Malocclusion Malocclusion Malocclusion, Angle Class II Stomatognathic Diseases Tooth Diseases

Age range

15 year–29 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Postgraduate orthodontic clinics, Jordan University of Science and Technology

Irbid, 21110, Jordan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Rate of space closure

    Time frame: four and half months

    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 outcomes

  1. Root resorption

    Time frame: Ten weeks

    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.

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Collaborators

  • University of Edinburgh
  • University of Sydney

Registry information

Official study 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

Acronym: RCT

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 17, 2019
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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