Efficiency of Piezo-Corticision in Accelerating Orthodontic Tooth Movement

Malocclusion, Angle Class I Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02549950
• Other study ID #: RC13/261/R
• Status: Recruiting
• Phase: N/A
• First received: September 11, 2015
• Last updated: September 14, 2015
• Start date: September 2015
• Est. completion date: July 2017

Study information

• Verified date: September 2015
• Source: King Abdullah International Medical Research Center
• Contact: Sally K Al-Yousef, Msc-Ortho
• Phone: 00966-11-8011111
• Email: alyousefsa[@]ngha.med.sa
• Is FDA regulated: No
• Health authority: Saudi Arabia: National Guard Health Affairs
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class I
• Malocclusion, Angle Class II
• Malocclusion; Angle Class II Division 1

Intervention

Procedure:
• Peizocorticision
Peizocorticision a non invasive procedure used in/ to accelerate orthodontic tooth movement
• Conventional Orthodontic Mechanics
Full Fixed Orthodontic Appliance with conventional orthodontic Mechanics

Locations

Country	Name	City	State
Saudi Arabia	National Guard Hospital	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
AL Yousef	King Abdullah International Medical Research Center

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of orthodontic canine movement		4-6 months	No
Secondary	Rate of orthodontic Incisor Retraction		4-6 months	No

External Links

•   Journal American Association of Orthodontist Dentofacial Orthopedic