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

NCT ID: NCT02977221

Last Updated: 2017-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-04-30

Brief Summary

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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

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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.

Conditions

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Surgical Incision Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Piezosurgery

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

Group Type EXPERIMENTAL

Piezosurgery

Intervention Type PROCEDURE

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.

Ordinary Alignment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Piezocision

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

27 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Omar Gibreal, DDS

Role: PRINCIPAL_INVESTIGATOR

MSc student, Oral and Maxillofacial Surgery Department, University of Damascus Dental School

Bassel Brad, DDS MSc PhD

Role: STUDY_DIRECTOR

Associate Professor of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Univ. of Damascus Dental School

Mohammad Y Hajeer, DDS MSc PhD

Role: STUDY_DIRECTOR

Associate Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School

Locations

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

Damascus, , Syria

Site Status

Countries

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Syria

References

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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.

Reference Type BACKGROUND
PMID: 22105680 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17726988 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24286911 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29931294 (View on PubMed)

Other Identifiers

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UDDS-OMFS-01-2016

Identifier Type: -

Identifier Source: org_study_id

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