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

Primary Purpose

Surgical Incision, Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Piezosurgery
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Incision focused on measuring corticotomy, piezocision, piezosurgery, acceleration of tooth movement, crowded anterior teeth

Eligibility Criteria

15 Years - 27 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Departments of Orthodontics and Oral and Maxillofcial Surgery, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Piezosurgery

Ordinary Alignment

Arm Description

Piezosurgery will be performed on the anterior lower segment of the dental arch in order to accelerate the correction of mandibular anterior crowding.

Treatment will be provided to the patients without any surgical interventions.

Outcomes

Primary Outcome Measures

Duration of tooth alignment
This outcome will be measured in 'days'.
Change in Tooth Alignment at one month
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.
Change in Tooth Alignment at two months
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.
Change in Tooth Alignment at last assessment time
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.

Secondary Outcome Measures

Full Information

First Posted
November 23, 2016
Last Updated
July 26, 2017
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT02977221
Brief Title
Efficacy of Piezosurgey Corticotomy (a Minimally Invasive Surgical Technique) in Accelerating Orthodontic Alignment
Official Title
Evaluation of the Efficacy of Flapless Corticotomy Accomplished by Piezosurgery in Accelerating Orthodontic Treatment of Crowding in Adults: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Incision, Malocclusion
Keywords
corticotomy, piezocision, piezosurgery, acceleration of tooth movement, crowded anterior teeth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Piezosurgery
Arm Type
Experimental
Arm Description
Piezosurgery will be performed on the anterior lower segment of the dental arch in order to accelerate the correction of mandibular anterior crowding.
Arm Title
Ordinary Alignment
Arm Type
No Intervention
Arm Description
Treatment will be provided to the patients without any surgical interventions.
Intervention Type
Procedure
Intervention Name(s)
Piezosurgery
Other Intervention Name(s)
Piezocision
Intervention Description
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.
Primary Outcome Measure Information:
Title
Duration of tooth alignment
Description
This outcome will be measured in 'days'.
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
Title
Change in Tooth Alignment at one month
Description
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.
Time Frame
Little Index of Irregularity will be measured at 30 days after the onset of treatment.
Title
Change in Tooth Alignment at two months
Description
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.
Time Frame
Little Index of Irregularity will be measured at 60 days after the onset of treatment.
Title
Change in Tooth Alignment at last assessment time
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult healthy patients , Male and female, Age range: 15-27 years. Severe crowding ≤ 7 (Little's irregularity index) Permanent occlusion. Exist all the Mandibular teeth (except third molars). Good oral and periodontal health: Probing depth<4 mm No radiographic evidence of bone loss . Gingival index≤ 1 Plaque index ≤ 1 Exclusion Criteria: Medical problems that affect tooth movement (corticosteroid, NSAIDs, …) Patients have anti indication for oral surgery ( medical - social - psycho) Presence of primary teeth in the mandibular arch Missing permanent mandibular teeth (except third molars). Poor oral hygiene or Current periodontal disease: Probing depth ≥ 4 mm radiographic evidence of bone loss Gingival index > 1 Plaque index > 1 Patient had previous orthodontic treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Gibreal, DDS
Organizational Affiliation
MSc student, Oral and Maxillofacial Surgery Department, University of Damascus Dental School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bassel Brad, DDS MSc PhD
Organizational Affiliation
Associate Professor of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Univ. of Damascus Dental School
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS MSc PhD
Organizational Affiliation
Associate Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School
Official's Role
Study Director
Facility Information:
Facility Name
Departments of Orthodontics and Oral and Maxillofcial Surgery, University of Damascus Dental School
City
Damascus
ZIP/Postal Code
DM20AM18
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22105680
Citation
Sebaoun JD, Surmenian J, Dibart S. [Accelerated orthodontic treatment with piezocision: a mini-invasive alternative to conventional corticotomies]. Orthod Fr. 2011 Dec;82(4):311-9. doi: 10.1051/orthodfr/2011142. Epub 2011 Nov 23. French.
Results Reference
background
PubMed Identifier
17726988
Citation
Vercellotti T, Podesta A. Orthodontic microsurgery: a new surgically guided technique for dental movement. Int J Periodontics Restorative Dent. 2007 Aug;27(4):325-31.
Results Reference
background
PubMed Identifier
24286911
Citation
Keser EI, Dibart S. Sequential piezocision: a novel approach to accelerated orthodontic treatment. Am J Orthod Dentofacial Orthop. 2013 Dec;144(6):879-89. doi: 10.1016/j.ajodo.2012.12.014.
Results Reference
background
PubMed Identifier
29931294
Citation
Gibreal O, Hajeer MY, Brad B. Efficacy of piezocision-based flapless corticotomy in the orthodontic correction of severely crowded lower anterior teeth: a randomized controlled trial. Eur J Orthod. 2019 Mar 29;41(2):188-195. doi: 10.1093/ejo/cjy042.
Results Reference
derived

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

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