The Effect of Corticotomy in En-mass Retraction

October 2, 2023 updated by: Ali Habiballah Hassan, King Abdulaziz University
  • To compare patients who will undergo orthodontics treatment involving upper premolar extraction for space of time whether with or without corticotomy by Piezotome.
  • Assess the safety of both methods of retraction in regard to the quality of the surrounding periodontium and roots of anterior teeth.
  • Monitor postoperative pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 26 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • On the basis of the diagnosis of the malocclusion, individuals who have Class I and Class II malocclusions and requiring extraction of premolars and retraction of anterior teeth will be selected (maxillary/mandibular or both).
  • Good oral hygiene, healthy gingiva and no evidence of bone loss as seen in radiograph.
  • Healthy systemic conditions.
  • No previous orthodontic treatment.
  • Patient needs to be in permanent dentition (hence, we need to define their age range).

Exclusion Criteria:

  • Patient with systemic disease.
  • Patient having any signs of active periodontal disease.
  • Patients on long-term corticosteroid therapy.
  • Persons taking medications that slows down bone metabolism.
  • Craniofacial anomalies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Orthodontic tooth movement group
This is the control group in which pateints will be treated by conventional orthodontic treatment and extraction of premolars without piezotome
Experimental: Corticotomy assisted orthodontic group
This is the study group in which patients will be treated by conventional orthodontic treatment aided by corticotomy procedure perfumed by using a piezotome.(piezotome assisted orthodontic tooth movement)
Procedure: piezotome assisted orthodontic tooth movement

Surgical procedure

  1. After local anesthesia, vertical interproximal incisions will be done under the interdental papilla, on the labial aspect of upper arch using a blade No. 15.
  2. The incisions will be kept minimal.
  3. The incisions go though the periosteum, which permit the blade to reach to the alveolar bone.
  4. A Piezo surgical knife will be used to make the cortical alveolar incision through the gingival incisions to a depth of approximately 3mm.
  5. As we will not use bone graft so we don't need use suturing after cortication.
  6. We give patient antibiotic and analgesic cover.
Other Names:
  • corticotomy assisted tooth movement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of tooth movement per time
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdulaziz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

December 25, 2016

First Submitted That Met QC Criteria

June 6, 2017

First Posted (Actual)

June 8, 2017

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 078-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

After publication, data can be shared with others upon request via email to the corresponding author.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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