NCT04601662

Brief Summary

The duration of orthodontic treatment is one of the exacerbation causes of orthodontic pain. Several methods have been suggested to reduce the duration of orthodontic treatment classified to surgical and non-surgical methods. Researchers used minimally invasive surgical methods like corticision, piezocision, micro-osteoperforation, and piezopuncture indicated that most of these methods can accelerate dental movement by 20 - 40%. The effect of corticision as a minimally invasive procedure on root resorption and dehiscence formation during orthodontic tooth movement has not been studied yet. Applying corticision on the lower anterior teeth using a surgical blade and a hammer may accelerate tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 15, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
Last Updated

October 26, 2020

Status Verified

October 1, 2020

Enrollment Period

1.7 years

First QC Date

October 20, 2020

Last Update Submit

October 20, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Root Length

    Cone-beam computed tomography imaging will be used for the lower jaw. Root length will be measured for each root of the six lower anterior teeth The change will be calculated between 'before' and 'after' images in mm.

    T1: one day before the beginning of the orthodontic treatment, T2: exactly at 12 months following the onset of orthodontic treatment

Secondary Outcomes (1)

  • Change in Dehiscence Proportion

    T1: one day before the beginning of the orthodontic treatment, T2: exactly at 12 months following the onset of orthodontic treatment

Study Arms (2)

Corticision

EXPERIMENTAL

Patients in this group will be subjected to corticision to accelerate orthodontic movement

Procedure: Corticision

Traditional treatment

ACTIVE COMPARATOR

Patients in this group will undergo normal traditional treatment without any acceleration method.

Other: Traditional Non-accelerated Treatment

Interventions

CorticisionPROCEDURE

A special instrument will be used to cut the cortex of the alveolar bone at different locations between the lower anterior teeth

Corticision

The normal sequence of treatment steps will be followed in this group without using any kind of acceleration methods

Traditional treatment

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age range between 18 and 24 years
  • Completion permanent dentition (except third molars)
  • Mild to moderate crowding (2-6 mm according to Little's index)
  • Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment

You may not qualify if:

  • Medical conditions that would affect tooth movement.
  • Cases which contraindication to oral surgery.
  • Previous orthodontic treatments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthodontic Department, University of Damascus Dental School

Damascus, 00963, Syria

Location

Related Publications (5)

  • Mandelaris GA, Neiva R, Chambrone L. Cone-Beam Computed Tomography and Interdisciplinary Dentofacial Therapy: An American Academy of Periodontology Best Evidence Review Focusing on Risk Assessment of the Dentoalveolar Bone Changes Influenced by Tooth Movement. J Periodontol. 2017 Oct;88(10):960-977. doi: 10.1902/jop.2017.160781.

    PMID: 28967331BACKGROUND
  • Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.

    PMID: 27129491BACKGROUND
  • Charavet C, Lambert F, Lecloux G, Le Gall M. [Accelerated orthodontic treatment using corticotomies: what are the minimally invasive alternatives?]. Orthod Fr. 2019 Mar;90(1):5-12. doi: 10.1051/orthodfr/2019002. Epub 2019 Apr 17. French.

    PMID: 30994445BACKGROUND
  • Makedonas D, Lund H, Hansen K. Root resorption diagnosed with cone beam computed tomography after 6 months and at the end of orthodontic treatment with fixed appliances. Angle Orthod. 2013 May;83(3):389-93. doi: 10.2319/042012-332.1. Epub 2012 Oct 23.

    PMID: 23092202BACKGROUND
  • Samandara A, Papageorgiou SN, Ioannidou-Marathiotou I, Kavvadia-Tsatala S, Papadopoulos MA. Evaluation of orthodontically induced external root resorption following orthodontic treatment using cone beam computed tomography (CBCT): a systematic review and meta-analysis. Eur J Orthod. 2019 Jan 23;41(1):67-79. doi: 10.1093/ejo/cjy027.

    PMID: 29771300BACKGROUND

Study Officials

  • Mohamad Radwan Sirri, DDS MSc

    PhD student, Orthodontics Department, University of Damascus Dental School

    PRINCIPAL INVESTIGATOR
  • Ahmad S Burhan, DDS MSc PhD

    Professor of Orthodontics, University of Damascus, Damascus, Syria

    STUDY DIRECTOR
  • Fehmieh R Nawaya, DDS MSc PhD

    Associate Professor of Pedodontics, Syrian Private University, Damascus, Syria

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2020

First Posted

October 26, 2020

Study Start

March 15, 2017

Primary Completion

November 15, 2018

Study Completion

February 15, 2019

Last Updated

October 26, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations