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Acceleration of Lower Anterior Teeth Leveling and Alignment Using Corticision

Primary Purpose

Crowding, Tooth

Status

Completed

Phase

Not Applicable

Locations

Syrian Arab Republic

Study Type

Interventional

Intervention

Traditional fixed appliance

Corticision

About this trial

This is an interventional treatment trial for Crowding, Tooth focused on measuring corticision, CBCT, Crowding

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Damascus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Traditional fixed appliance

Fixed appliance and corticision

Arm Description

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

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

Outcomes

Primary Outcome Measures

Speed of lower teeth movement.

The speed of lower teeth movement during leveling and alignment stage will be measured and compared between groups.

Secondary Outcome Measures

Changes of lower teeth torque

The torque changes of the lower teeth will be evaluated and compared between the 2 groups using CBCT.

Changes of lower teeth tipping

The tipping changes of the lower teeth will be evaluated and compared between the 2 groups using CBCT.

Full Information

NCT ID

NCT03310086

First Posted

October 9, 2017

Last Updated

July 27, 2018

Sponsor

Damascus University

1. Study Identification

Unique Protocol Identification Number

NCT03310086

Brief Title

Acceleration of Lower Anterior Teeth Leveling and Alignment Using Corticision

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

January 2017 (Actual)

Primary Completion Date

December 20, 2017 (Actual)

Study Completion Date

July 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crowding, Tooth

Keywords

corticision, CBCT, Crowding

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Traditional fixed appliance

Arm Type

Experimental

Arm Description

Arm Title

Fixed appliance and corticision

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Traditional fixed appliance

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Corticision

Intervention Description

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

Primary Outcome Measure Information:

Title

Speed of lower teeth movement.

Description

The speed of lower teeth movement during leveling and alignment stage will be measured and compared between groups.

Time Frame

After the leveling and alignment stage of the lower teeth, which will take approximately 9 months

Secondary Outcome Measure Information:

Title

Changes of lower teeth torque

Description

The torque changes of the lower teeth will be evaluated and compared between the 2 groups using CBCT.

Time Frame

Changes will be evaluated before and after the lower teeth leveling and alignment stage, which will take approximately 8 months

Title

Changes of lower teeth tipping

Description

The tipping changes of the lower teeth will be evaluated and compared between the 2 groups using CBCT.

Time Frame

Changes will be evaluated before and after the lower teeth leveling and alignment stage, which will take approximately 8 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmad S Burhan, PhD.

Organizational Affiliation

Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

Official's Role

Study Chair

Facility Information:

Facility Name

Damascus University

City

Damascus

ZIP/Postal Code

00963

Country

Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

22135148

Citation

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.

Results Reference

result

PubMed Identifier

26599124

Citation

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.

Results Reference

result

PubMed Identifier

23273363

Citation

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.

Results Reference

result

PubMed Identifier

24182579

Citation

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.

Results Reference

result

PubMed Identifier

22812378

Citation

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.

Results Reference

result

PubMed Identifier

23810039

Citation

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.

Results Reference

result

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Acceleration of Lower Anterior Teeth Leveling and Alignment Using Corticision

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