NCT02549950

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 15, 2015

Status Verified

September 1, 2015

Enrollment Period

9 months

First QC Date

September 11, 2015

Last Update Submit

September 14, 2015

Conditions

Malocclusion, Angle Class IMalocclusion; Angle Class II Division 1

Keywords

Accelerated orthodontic tooth movement (AOTM)Peizo-corticission

Outcome Measures

Primary Outcomes (1)

  • Rate of orthodontic canine movement

    4-6 months

Secondary Outcomes (1)

  • Rate of orthodontic Incisor Retraction

    4-6 months

Study Arms (2)

Conventional OrthodonticTreatment

ACTIVE COMPARATOR

Conventional orthodontic mechanics: canine and incisor retraction

Procedure: Conventional Orthodontic Mechanics

Accelerated Tooth Movement

EXPERIMENTAL

Accelerated orthodontics: Peizo-Corticision Accelerated canine and Incisor retraction

Procedure: Peizocorticision

Interventions

PeizocorticisionPROCEDURE

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

Also known as: AOTM Accelerated Orthodontic Tooth Movement
Accelerated Tooth Movement
Conventional Orthodontic MechanicsPROCEDURE

Full Fixed Orthodontic Appliance with conventional orthodontic Mechanics

Also known as: Conv Orth Mech
Conventional OrthodonticTreatment

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Guard Hospital

Riyadh, 11426, Saudi Arabia

RECRUITING

Related 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. No abstract available.

    PMID: 23810039BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class IMalocclusion, Angle Class II

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • Sally K Al-Yousef, MSc-Ortho

    KAIMRC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sally K Al-Yousef, Msc-Ortho

CONTACT

00966-11-8011111alyousefsa@ngha.med.sa

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sally K Al Yousef BDS; AEGD; GPR; MSc-Orthodontics

Study Record Dates

First Submitted

September 11, 2015

First Posted

September 15, 2015

Study Start

September 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2017

Last Updated

September 15, 2015

Record last verified: 2015-09

Locations

SA(1)