Evaluation of the Root Resorption and Dehiscence Formation Between Two Methods of Leveling and Alignment of Lower Teeth

October 20, 2020 updated by: Damascus University

Evaluation of Corticision-Based Acceleration of Lower Anterior Teeth Alignment on Root Resorption and Dehiscence Formation Using CBCT

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Orthodontically induced external root resorption accompanying orthodontic treatment is defined as a microscopic loss of root tissue as a result of the inflammatory reaction that occurs in the area of application of orthodontic force. It can be diagnosed and measured using conventional radiography or cone-beam computed tomography (CBCT).

Dehiscence is a loss of alveolar bone on the facial (rarely lingual) aspect of a tooth that leaves a characteristic v-shaped, root-exposed defect from the cementoenamel junction apically. Bone dehiscence cannot be detected through conventional radiography or clinical examination. Actually, CBCT can be considered the best accessible technique providing 3D data.

Corticision is one of the minimally invasive surgical procedures that is not associated with flap lifting. It was used to accelerate tooth movement in animals and case report studies. Its application on humans may aggravate their fear and anxiety towards the pain that may accompany this technique.

No randomized controlled trial (RCT) has compared flapless corticision in the non-extraction-based orthodontic decrowding of lower anterior teeth (LAT) with the conventional treatment in terms of external apical root resorption (EARR) and dehiscence formation (DF).

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, 00963
        • Orthodontic Department, University of Damascus Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Corticision
Patients in this group will be subjected to corticision to accelerate orthodontic movement
Procedure: Corticision
A special instrument will be used to cut the cortex of the alveolar bone at different locations between the lower anterior teeth
ACTIVE_COMPARATOR: Traditional treatment
Patients in this group will undergo normal traditional treatment without any acceleration method.
Other: Traditional Non-accelerated Treatment
The normal sequence of treatment steps will be followed in this group without using any kind of acceleration methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Root Length
Time Frame: T1: one day before the beginning of the orthodontic treatment, T2: exactly at 12 months following the onset of orthodontic treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Dehiscence Proportion
Time Frame: T1: one day before the beginning of the orthodontic treatment, T2: exactly at 12 months following the onset of orthodontic treatment
Cone-beam computed tomography imaging will be used for the lower jaw. Any V-shaped bone defect located buccally or lingually in the lower anterior region involving bone margin is preliminarily identified as dehiscence. This is going to be measured and the proportion of the presence of such defects will be calculated on two different occasions (T1 and T2).
T1: one day before the beginning of the orthodontic treatment, T2: exactly at 12 months following the onset of orthodontic treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: Mohamad Radwan Sirri, DDS MSc, PhD student, Orthodontics Department, University of Damascus Dental School
  • Study Director: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 15, 2017

Primary Completion (ACTUAL)

November 15, 2018

Study Completion (ACTUAL)

February 15, 2019

Study Registration Dates

First Submitted

October 20, 2020

First Submitted That Met QC Criteria

October 20, 2020

First Posted (ACTUAL)

October 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Ortho-06-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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