Acceleration of Lower Anterior Teeth Leveling and Alignment Using Corticision

July 27, 2018 updated by: Damascus University

Evaluation of the Efficiency of Corticision on Accelerating of Leveling and Alignment Lower Crowded Incisors Using Cone Beam Computed Tomography - A Randomized Controlled Trial

This experimental study will evaluate the effect of corticision on accelerating the leveling and alignment of lower crowded incisors compared with the control untreated group using cone beam computed tomography.

The study sample will consist of 26 patients with less than 6 mm crowding. The sample will be allocated randomly into two experimental groups.

The brackets and passive SS wire will be applied with radiographic metal guides between each tooth to allow for accurate corticision site 2 mm below the gingival papilla and to prevent tooth roots injury. The dentoalveolar changes occurring after leveling and alignment of lower anterior teeth will be evaluated using CBCT radiographs, Frequency, degree of root resorption, and the incidence of bone dehiscence will be assessed in relation to initial situation.

Study Overview

Status

Completed

Conditions

Detailed Description

Crowding is the most common form of malocclusion. Different methods have been used to resolve crowding, including extraction and nonextraction. Corticision is an important methods to accelerate tooth movement in crowded cases. Cortical bone incision without flap elevation enhances turnover rate of surrounding structures and decreases the time for leveling and alignment. In orthodontics, CBCT imaging has been applied to evaluate impacted teeth and root resorption. But the data are very rare regarding the application of CBCT in tooth movement. So CBCT will be used in this research to evaluate the amount of external apical root resorption (EARR) and presence of dehiscence in the lower anterior teeth in the crowded cases. Furthermore, the duration of alignment will be compared between corticision group and non-corticision group.

Study Type

Interventional

Enrollment (Actual)

26

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

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 25 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients age 18 years or more
  • complete permanent dentition with second molars
  • crowding of less than 6 mm
  • good healthy patients without systematic diseases
  • absence of spaces in the lower dental arch
  • orthodontic treatment protocol does not required extraoral appliances, intraoral elastics, and expansion during leveling and alignment in the lower arch
  • good oral hygiene
  • absence of periodontal lesion

Exclusion Criteria:

  • patients with syndromes, clefts, or craniofacial abnormalities or systematic diseases
  • poor oral hygiene or periodontal lesion
  • previous orthodontic treatment.
  • Inability for brackets bonding in lower anterior teeth
  • presence of extreme skeletal discrepancy in vertical , transverse and anteroposterior relations
  • Delay rebonding of any loosing brackets for more than one week in the lower anterior teeth

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: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Traditional fixed appliance
Fixed orthodontic appliances will be applied for aligning and leveling of lower anterior teeth up to 19*25 stainless steel wires using traditional brackets; American Orthodontics Master® MBT 0.022" Brackets
aligning and leveling of lower anterior teeth using traditional fixed appliance.
EXPERIMENTAL: Fixed appliance and corticision
Fixed orthodontic appliances with corticison will be applied for aligning and leveling of lower anterior teeth up to 19*25 stainless steel wires using traditional brackets; American Orthodontics Master® MBT 0.022" Brackets
aligning and leveling of lower anterior teeth using traditional fixed appliance.
Corticison, cortical bone incision without flap elevation, will be applied to the lower anterior teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speed of lower teeth movement.
Time Frame: After the leveling and alignment stage of the lower teeth, which will take approximately 9 months
The speed of lower teeth movement during leveling and alignment stage will be measured and compared between groups.
After the leveling and alignment stage of the lower teeth, which will take approximately 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of lower teeth torque
Time Frame: Changes will be evaluated before and after the lower teeth leveling and alignment stage, which will take approximately 8 months
The torque changes of the lower teeth will be evaluated and compared between the 2 groups using CBCT.
Changes will be evaluated before and after the lower teeth leveling and alignment stage, which will take approximately 8 months
Changes of lower teeth tipping
Time Frame: Changes will be evaluated before and after the lower teeth leveling and alignment stage, which will take approximately 8 months
The tipping changes of the lower teeth will be evaluated and compared between the 2 groups using CBCT.
Changes will be evaluated before and after the lower teeth leveling and alignment stage, which will take approximately 8 months

Collaborators and Investigators

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

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.

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)

January 1, 2017

Primary Completion (ACTUAL)

December 20, 2017

Study Completion (ACTUAL)

July 15, 2018

Study Registration Dates

First Submitted

October 9, 2017

First Submitted That Met QC Criteria

October 13, 2017

First Posted (ACTUAL)

October 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 30, 2018

Last Update Submitted That Met QC Criteria

July 27, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Ortho-07-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University

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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