Efficiency of Piezo-Corticision in Accelerating Orthodontic Tooth Movement

Efficiency and Efficacy of Peizo-Coticision in Reducing Orthodontic Treatment Time: Randomized Clinical Trial

The purpose of this study is to provide evidence on the effectiveness, the efficiency and efficacy of Peizo-Corticission in accelerating orthodontic tooth movement and reducing orthodontic treatment time.

Study Overview

• Status: Unknown
• Conditions: Malocclusion, Angle Class I; Malocclusion; Angle Class II Division 1
• Intervention / Treatment: Procedure: Conventional Orthodontic Mechanics; Procedure: Peizocorticision

Detailed Description

1 Aim of the study- Part I:

This prospective controlled clinical trial (CCT), Split Mouth Design is conducted to assess the efficiency of piezo-corticision in accelerating tooth movement and in reducing treatment time during retraction of canine teeth in class II div 1 subjects.

Specific aim- Part I:

A- To compare rate of tooth retraction between piezo-corticised and the conventionally orthodontically moved canines

B- To compare length of treatment of both approaches.

2- Objectives of the Study Part II:

This prospective randomized controlled clinical trial (RCT) is designed to assess the efficiency of piezo-corticision in accelerating tooth movement and in reducing treatment time during retraction of anterior teeth in class II div 1 and class 1 bi-maxillary protrusive subjects.

Specific aim Part II:

1. To compare rate of tooth retraction between piezo-corticised and the conventionally orthodontically moved incisors
2. To compare length of treatment of both approaches.
3. To evaluate the quality of treatment outcome of both treatment approaches according to American Board of Orthodontics (ABO) standards.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sally K Al-Yousef, Msc-Ortho; Phone Number: 14036 00966-11-8011111; Email: alyousefsa@ngha.med.sa

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11426
    • Recruiting
    • National Guard Hospital
    • Contact: SALLY K AL-YOUSEF; Phone Number: 14036 00966118011111; Email: alyousefsa@ngha.med.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Study Subjects for Part I and Part II:

Inclusion:

• Voluntary participation of patients only
• Able to follow instruction, able to understand the consent form and sign it.
• Adult Female and Male Saudi patients 15-35 y.o
• Subjects who are none smokers
• Subjects with good health according to American Society of Anesthesiology ASA-I with full permanent dentition regardless of the third molars.
• Subjects with good periodontal and gingival health: Gingival Index GI≤ 1
• Subjects with a none gummy smile,
• Subjects with full complement of permanent caries-free dentition; Restored teeth should be of proper sound intact fillings
• Subjects without root anomalies
• Subjects with mild-moderate skeletal and dental cephalometric measurements: OB ≤ 40%, OJ ≤ 6, ANB ≤ 5 °, SN-GOGN ≤ 29 °, Subjects' dentition Angle classification class II div 1, 3mm molar and canine occlussal relationship; and subjects with class 1 Bi-maxillary protrusion

Exclusion:

• Subjects younger than 15 y.o
• Subjects who cannot comprehend the surgical procedure and who cannot consent for themselves
• Subjects who are medically classified as ASA-II, III
• Subjects who are taking any systemic or local medications especially Insulin, non-steroidal anti-inflammatory drugs, bisphosphonate, corticosteroids
• Subjects who are pregnant
• Subjects who are smokers
• Subjects with craniofacial syndromes: cleft lip and palate; or facial trauma
• Subjects with unhealthy or compromised periodontium
• Subjects with a gummy smile
• Subjects with inadequately treated endodontic and dental fillings problems
• Subjects with previous root resorption or dental developmental anomalies
• Subjects who had previous orthodontic treatment
• Subjects with TMJ signs and symptoms; Mandibular functional shift
• Subjects with extreme skeletal and dental class II: SN-GOGN ≥ 32°, OJ ≥ 6mm
• Subjects will be excluded if broken brackets or lost coils which have not been replaced immediately within few days from breakage or loss.
• Subjects will be excluded if any of mini-screws failed during treatment
• Subjects who become medically unfit during course of trial

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional OrthodonticTreatment; Conventional orthodontic mechanics: canine and incisor retraction	Procedure: Conventional Orthodontic Mechanics; Full Fixed Orthodontic Appliance with conventional orthodontic Mechanics; Other Names: Conv Orth Mech
Experimental: Accelerated Tooth Movement; Accelerated orthodontics: Peizo-Corticision Accelerated canine and Incisor retraction	Procedure: Peizocorticision; Peizocorticision a non invasive procedure used in/ to accelerate orthodontic tooth movement; Other Names: AOTM Accelerated Orthodontic Tooth Movement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of orthodontic canine movement	4-6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of orthodontic Incisor Retraction	4-6 months

Collaborators and Investigators

• Sponsor: AL Yousef
• Collaborators: King Abdullah International Medical Research Center
• Investigators: Principal Investigator: Sally K Al-Yousef, MSc-Ortho, KAIMRC

Publications and helpful links

General Publications

• Mathews DP, Kokich VG. Accelerating tooth movement: the case against corticotomy-induced orthodontics. Am J Orthod Dentofacial Orthop. 2013 Jul;144(1):5-13. doi: 10.1016/j.ajodo.2013.04.008. No abstract available.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: September 11, 2015
• First Submitted That Met QC Criteria: September 14, 2015
• First Posted (Estimate): September 15, 2015

Study Record Updates

• Last Update Posted (Estimate): September 15, 2015
• Last Update Submitted That Met QC Criteria: September 14, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Accelerated orthodontic tooth movement (AOTM); Peizo-corticission
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite; Malocclusion, Angle Class I
• Other Study ID Numbers: RC13/261/R