Efficiency of Piezo-Corticision in Accelerating Orthodontic Tooth Movement

NCT ID: NCT02549950

Last Updated: 2015-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-07-31

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Conventional OrthodonticTreatment

Conventional orthodontic mechanics: canine and incisor retraction

Group Type: ACTIVE_COMPARATOR

Conventional Orthodontic Mechanics

Intervention Type: PROCEDURE

Full Fixed Orthodontic Appliance with conventional orthodontic Mechanics

Accelerated Tooth Movement

Accelerated orthodontics: Peizo-Corticision Accelerated canine and Incisor retraction

Group Type: EXPERIMENTAL

Peizocorticision

Intervention Type: PROCEDURE

Peizocorticision a non invasive procedure used in/ to accelerate orthodontic tooth movement

Interventions

Peizocorticision

Peizocorticision a non invasive procedure used in/ to accelerate orthodontic tooth movement

Intervention Type: PROCEDURE

Conventional Orthodontic Mechanics

Full Fixed Orthodontic Appliance with conventional orthodontic Mechanics

Intervention Type: PROCEDURE

Other Intervention Names

AOTM Accelerated Orthodontic Tooth Movement; Conv Orth Mech

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King Abdullah International Medical Research Center

OTHER

Sponsor Role: collaborator

AL Yousef

OTHER

Sponsor Role: lead

Responsible Party

AL Yousef

Sally K Al Yousef BDS; AEGD; GPR; MSc-Orthodontics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sally K Al-Yousef, MSc-Ortho

Role: PRINCIPAL_INVESTIGATOR

KAIMRC

Locations

National Guard Hospital

Riyadh, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Sally K Al-Yousef, Msc-Ortho

Role: CONTACT

alyousefsa@ngha.med.sa

00966-11-8011111 ext. 14036

Facility Contacts

SALLY K AL-YOUSEF

Role: primary

alyousefsa@ngha.med.sa

00966118011111 ext. 14036

References

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.

Reference Type: BACKGROUND

PMID: 23810039 (View on PubMed)

Other Identifiers

RC13/261/R

Identifier Type: -

Identifier Source: org_study_id