Efficacy of Piezosurgey Corticotomy (a Minimally Invasive Surgical Technique) in Accelerating Orthodontic Alignment

July 26, 2017 updated by: Damascus University

Evaluation of the Efficacy of Flapless Corticotomy Accomplished by Piezosurgery in Accelerating Orthodontic Treatment of Crowding in Adults: a Randomized Controlled Trial

Applying flapless piezocision corticotomies on the alveolar bone and separating anterior mandibular teeth using a piezosurgery device (i.e. ultrasonic waves that perform very accurate incisions without any sutures following this procedure) may improve the speed of tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups. The efficacy of this procedure on 18 patients (experimental group) will be evaluated,whereas the second group (control group) will receive a traditional orthodontic therapy. The time required to achieve complete alignment of crowded mandibular anterior teeth (from canine to canine) will be compared between the two groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

According to the American Association of Orthodontists (AAO), the length of comprehensive orthodontic treatment ranges between 18-30 months, depending on treatment options and individual characteristics. In addition, orthodontic treatment time ranges between 25-35 months for extraction therapies, respectively. Reducing orthodontic treatment time is one of the main goals for orthodontists, due to problems such as root resorption, periodontal disease and caries that are associated with prolonged treatment time.

Many techniques have been introduced to accelerate orthodontic tooth movement; surgical and non-surgical. The surgical approach is the most clinically applied and most tested with known predictions and stable results. Surgical approaches usually vary from total block osteotomies to flapless partial corticotomies .In spite of corticotomy-assisted orthodontic treatment efficiency, the invasiveness of these procedures (i.e. requiring full mucoperiosteal flaps elevation) might have limited their widespread acceptance among orthodontists and patients. Therefore, more conservative flapless corticotomy techniques have recently been proposed. These procedures can be accomplished in a reasonably short periods that might produce less pain and discomfort, so we will gain better patient acceptance. Although various techniques of flapless corticotomy have been reported to be successful in practice, scientific evidence for their effectiveness so far has been limited to case series and a few clinical trials, generally with small groups. This study aims to provide some evidence about the efficacy of piezosurgery in a flapless technique to align crowded lower anterior teeth using a parallel-group randomized controlled trial study design.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, DM20AM18
        • Departments of Orthodontics and Oral and Maxillofcial Surgery, University of Damascus Dental School

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

15 years to 27 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult healthy patients , Male and female, Age range: 15-27 years.
  2. Severe crowding ≤ 7 (Little's irregularity index)
  3. Permanent occlusion.
  4. Exist all the Mandibular teeth (except third molars).

  5. Good oral and periodontal health:

    • Probing depth<4 mm
    • No radiographic evidence of bone loss .
    • Gingival index≤ 1
    • Plaque index ≤ 1

Exclusion Criteria:

  1. Medical problems that affect tooth movement (corticosteroid, NSAIDs, …)
  2. Patients have anti indication for oral surgery ( medical - social - psycho)
  3. Presence of primary teeth in the mandibular arch
  4. Missing permanent mandibular teeth (except third molars).

  5. Poor oral hygiene or Current periodontal disease:

    • Probing depth ≥ 4 mm
    • radiographic evidence of bone loss
    • Gingival index > 1
    • Plaque index > 1
  6. Patient had previous orthodontic treatment

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Piezosurgery
Piezosurgery will be performed on the anterior lower segment of the dental arch in order to accelerate the correction of mandibular anterior crowding.
Procedure: Piezosurgery
The device tip will be used to to create small vertical incisions into the cortex of the dento-alveolar process of the lower anterior teeth.
Other Names:
  • Piezocision
No Intervention: Ordinary Alignment
Treatment will be provided to the patients without any surgical interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of tooth alignment
Time Frame: This will be measured at the end of treatment by calculating the time required time (in days) to achieve complete alignment of lower anterior teeth from the first day of treatment and up to 120-150 days of observation
This outcome will be measured in 'days'.
This will be measured at the end of treatment by calculating the time required time (in days) to achieve complete alignment of lower anterior teeth from the first day of treatment and up to 120-150 days of observation
Change in Tooth Alignment at one month
Time Frame: Little Index of Irregularity will be measured at 30 days after the onset of treatment.
This index is measured on plaster study casts of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
Little Index of Irregularity will be measured at 30 days after the onset of treatment.
Change in Tooth Alignment at two months
Time Frame: Little Index of Irregularity will be measured at 60 days after the onset of treatment.
This index is measured on plaster study casts of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
Little Index of Irregularity will be measured at 60 days after the onset of treatment.
Change in Tooth Alignment at last assessment time
Time Frame: Little Index of Irregularity will be measured when a complete alignment is achieved; this is expected between 90 to 120 days after the onset of treatment.
This index is measured on plaster study casts of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
Little Index of Irregularity will be measured when a complete alignment is achieved; this is expected between 90 to 120 days after the onset of treatment.

Collaborators and Investigators

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

Sponsor

Damascus University

Investigators

  • Principal Investigator: Omar Gibreal, DDS, MSc student, Oral and Maxillofacial Surgery Department, University of Damascus Dental School
  • Study Director: Bassel Brad, DDS MSc PhD, Associate Professor of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Univ. of Damascus Dental School
  • Study Director: Mohammad Y Hajeer, DDS MSc PhD, Associate Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School

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

March 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 25, 2016

First Posted (Estimate)

November 30, 2016

Study Record Updates

Last Update Posted (Actual)

July 27, 2017

Last Update Submitted That Met QC Criteria

July 26, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-OMFS-01-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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