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Acceleration of Lower Anterior Teeth Leveling and Alignment Using Corticision

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ClinicalTrials.gov Identifier: NCT03310086
Recruitment Status : Completed
First Posted : October 16, 2017
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Damascus University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Crowding, Tooth Device: Traditional fixed appliance Procedure: Corticision Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficiency of Corticision on Accelerating of Leveling and Alignment Lower Crowded Incisors Using Cone Beam Computed Tomography - A Randomized Controlled Trial
Actual Study Start Date : January 2017
Actual Primary Completion Date : December 20, 2017
Actual Study Completion Date : July 15, 2018

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
Device: Traditional fixed appliance
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
Device: Traditional fixed appliance
aligning and leveling of lower anterior teeth using traditional fixed appliance.

Procedure: Corticision
Corticison, cortical bone incision without flap elevation, will be applied to the lower anterior teeth




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310086


Locations
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Syrian Arab Republic
Damascus University
Damascus, Syrian Arab Republic, 00963
Sponsors and Collaborators
Damascus University
Investigators
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Study Chair: Ahmad S Burhan, PhD. Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

Publications of Results:
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Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT03310086     History of Changes
Other Study ID Numbers: UDDS-Ortho-07-2017
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Damascus University:
corticision
CBCT
Crowding

Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases