- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03310086
Acceleration of Lower Anterior Teeth Leveling and Alignment Using Corticision
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Damascus, Syrian Arab Republic, 00963
- Damascus University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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aligning and leveling of lower anterior teeth using traditional fixed appliance.
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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 |
|---|---|---|
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Speed of lower teeth movement.
Time Frame: After the leveling and alignment stage of the lower teeth, which will take approximately 9 months
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The speed of lower teeth movement during leveling and alignment stage will be measured and compared between groups.
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After the leveling and alignment stage of the lower teeth, which will take approximately 9 months
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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
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The torque changes of the lower teeth will be evaluated and compared between the 2 groups using CBCT.
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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
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The tipping changes of the lower teeth will be evaluated and compared between the 2 groups using CBCT.
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Changes will be evaluated before and after the lower teeth leveling and alignment stage, which will take approximately 8 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Guo QY, Zhang SJ, Liu H, Wang CL, Wei FL, Lv T, Wang NN, Liu DX. Three-dimensional evaluation of upper anterior alveolar bone dehiscence after incisor retraction and intrusion in adult patients with bimaxillary protrusion malocclusion. J Zhejiang Univ Sci B. 2011 Dec;12(12):990-7. doi: 10.1631/jzus.B1100013.
- Park YG. Corticision: A Flapless Procedure to Accelerate Tooth Movement. Front Oral Biol. 2016;18:109-17. doi: 10.1159/000351904. Epub 2015 Nov 24.
- Ponder SN, Benavides E, Kapila S, Hatch NE. Quantification of external root resorption by low- vs high-resolution cone-beam computed tomography and periapical radiography: A volumetric and linear analysis. Am J Orthod Dentofacial Orthop. 2013 Jan;143(1):77-91. doi: 10.1016/j.ajodo.2012.08.023.
- Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.
- Castro IO, Alencar AH, Valladares-Neto J, Estrela C. Apical root resorption due to orthodontic treatment detected by cone beam computed tomography. Angle Orthod. 2013 Mar;83(2):196-203. doi: 10.2319/032112-240.1. Epub 2012 Jul 19.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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