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Status unknownNCT02549950Updated Sep 15, 2015

Efficiency of Piezo-Corticision in Accelerating Orthodontic Tooth Movement

An interventional study of Peizocorticision and Conventional Orthodontic Mechanics in Malocclusion, Angle Class I and Malocclusion; Angle Class II Division 1, sponsored by AL Yousef. Status unknown at 1 site in Saudi Arabia. Open to participants aged 15 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-15.

Sponsored by AL Yousef · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Sep 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
15 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

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

Keywords

  • Accelerated orthodontic tooth movement (AOTM)
  • Peizo-corticission
03

In context

Malocclusion, Angle Class I

35 studies on the registry are indexed under Malocclusion, Angle Class I; 10 are open to participants now.

This study's planned enrollment of 60 is above the median of 32 across 31 interventional studies indexed under Malocclusion, Angle Class I.

Browse Malocclusion, Angle Class I studies →

Lead sponsor

This is the only study on the registry with AL Yousef as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Study Subjects for Part I and Part II:

Inclusion criteria

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 criteria

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,
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Conventional OrthodonticTreatment

    Conventional orthodontic mechanics: canine and incisor retraction

    Procedure: Conventional Orthodontic Mechanics

  • Experimental
    Accelerated Tooth Movement

    Accelerated orthodontics: Peizo-Corticision Accelerated canine and Incisor retraction

    Procedure: Peizocorticision

Interventions

  • ProcedurePeizocorticision

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

    Also known as: AOTM Accelerated Orthodontic Tooth Movement

  • ProcedureConventional Orthodontic Mechanics

    Full Fixed Orthodontic Appliance with conventional orthodontic Mechanics

    Also known as: Conv Orth Mech

06

What researchers measure

Primary outcomes

  1. Rate of orthodontic canine movement

    Time frame: 4-6 months

Secondary outcomes

  1. Rate of orthodontic Incisor Retraction

    Time frame: 4-6 months

07

Study locations

1 of 1 sites recruiting
  • National Guard Hospital
    Riyadh, 11426, Saudi Arabia
    Recruiting
08

References and documents

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. PubMed 23810039 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2015, a primary completion of Jun 2016 and a completion of Jul 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2015
First posted
Sep 15, 2015
Start
Sep 2015
Primary completionEst.
Jun 2016
CompletionEst.
Jul 2017
Last update
Sep 15, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02549950
Lead sponsor
AL Yousef
Collaborators
King Abdullah International Medical Research Center
Responsible party
AL Yousef (Sally K Al Yousef BDS; AEGD; GPR; MSc-Orthodontics, King Abdullah International Medical Research Center) — Sponsor-investigator
First posted
Sep 15, 2015
Start date
Sep 2015
Primary completion
Jun 2016 (estimated)
Completion
Jul 2017 (estimated)
Last update
Sep 15, 2015

Study contacts

Sally K Al-Yousef, Msc-Ortho
Contact
alyousefsa@ngha.med.sa
00966-11-8011111 ext. 14036
Sally K Al-Yousef, MSc-Ortho
principal investigator · KAIMRC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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