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

NCT02977221 | Completed DMC

• 1 other identifier: UDDS-OMFS-01-2016
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Incision; Malocclusion

Keywords

corticotomy; piezocision; piezosurgery; acceleration of tooth movement; crowded anterior teeth

Outcome Measures

Primary Outcomes (4)

• Duration of tooth alignment

  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

  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

  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

  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.

Study Arms (2)

Piezosurgery

EXPERIMENTAL

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

Ordinary Alignment

NO INTERVENTION

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

Interventions

Piezosurgery 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.

Also known as: Piezocision

Piezosurgery

Eligibility Criteria

• Age: 15 Years - 27 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

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

Damascus, DM20AM18, Syria

Location

Related Publications (4)

• 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.

  PMID: 22105680 BACKGROUND

• 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.

  PMID: 17726988 BACKGROUND

• 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.

  PMID: 24286911 BACKGROUND

• 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.

  PMID: 29931294 DERIVED

MeSH Terms

Conditions

Surgical Wound; Malocclusion

Interventions

Piezosurgery

Condition Hierarchy (Ancestors)

Wounds and Injuries; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Omar Gibreal, DDS

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

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: November 30, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: April 1, 2017
• Last Updated: July 27, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)