Treatment of Crowding Without Extraction Using Self Ligating Brackets

NCT ID: NCT02996292

Last Updated: 2018-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-07-19

Brief Summary

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This experimental study will evaluate the effect of active and passive self-ligating brackets in treatment of crowding, compared with the control group of conventional brackets in class I malocclusion without extraction.

The study sample will consist of 66 patients with 3-6mm crowding. The sample will be allocated randomly into two experimental groups, in addition to a control group.

The brackets will be applied using indirect bonding method for all patients. The dentoalveolar changes occurring after leveling and alignment teeth will be assessed by using CBCT radiographs; pre and post- treatment changes for each group will be evaluated individually.

Detailed Description

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Producing of modern and various brackets systems both self- ligating and conventional make the 3 dimensional important in order to evaluate the root positions and to investigate EARR in multi root teeth, so the research will depend on CBCT to carry out these purposes in our study. Beside to compare the duration of alignment among groups.

Fixed appliances will be applied into three groups as 1. Active self ligating brackets (ASLB), 2. Passive self ligating brackets (PSLB), 3. Conventional brackets (CB) until reach to wire 19\*25 S.S upper and lower. During leveling, thermal activated wires will be used in all patients.

CBCT images will be done before and after leveling and alignment of teeth to compare dentoalveolar changes between study groups.

Conditions

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Crowding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Traditional brackets

Fixed orthodontic appliances will be applied for aligning and leveling of teeth up to 19\*25 stainless steel wires using traditional brackets; American Orthodontics Master® MBT 0.022" Brackets

Group Type EXPERIMENTAL

Traditional brackets

Intervention Type DEVICE

Treating of crowding using traditional brackets

Active self-ligating brackets

Fixed orthodontic appliances will be applied for aligning and leveling of teeth up to 19\*25 stainless steel wires using active self-ligating brackets; American orthodontics active self-ligating Empower® MBT 0.022"

Group Type EXPERIMENTAL

Active self-ligating brackets

Intervention Type DEVICE

Treating of crowding using active self-ligating brackets

Passive self-ligating brackets

Fixed orthodontic appliances will be applied for aligning and leveling of teeth up to 19\*25 stainless steel wires using passive self-ligating brackets; American orthodontics passive self-ligating Empower® MBT 0.022"

Group Type EXPERIMENTAL

Passive self-ligating brackets

Intervention Type DEVICE

Treating of crowding using passive self-ligating brackets

Interventions

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Traditional brackets

Treating of crowding using traditional brackets

Intervention Type DEVICE

Active self-ligating brackets

Treating of crowding using active self-ligating brackets

Intervention Type DEVICE

Passive self-ligating brackets

Treating of crowding using passive self-ligating brackets

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients permanent dentition stage.
* crowding up to 6 mm
* Class I relationship.
* Good oral hygiene.

Exclusion Criteria

* Poor oral hygiene.
* Previous orthodontic treatment.
* Patients with syndromes, clefts, or craniofacial abnormalities.
* Class II or III skeletal anteroposterior relationship.
* Crowding less than 3mm and more than 6mm.
Minimum Eligible Age

14 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmad S Burhan, PhD.

Role: STUDY_CHAIR

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

Locations

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Damascus University

Damascus, , Syria

Site Status

Countries

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Syria

References

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Badawi HM, Toogood RW, Carey JP, Heo G, Major PW. Torque expression of self-ligating brackets. Am J Orthod Dentofacial Orthop. 2008 May;133(5):721-8. doi: 10.1016/j.ajodo.2006.01.051.

Reference Type RESULT
PMID: 18456146 (View on PubMed)

Chan EK, Darendeliler MA, Petocz P, Jones AS. A new method for volumetric measurement of orthodontically induced root resorption craters. Eur J Oral Sci. 2004 Apr;112(2):134-9. doi: 10.1111/j.1600-0722.2004.00118.x.

Reference Type RESULT
PMID: 15056110 (View on PubMed)

Chen SS, Greenlee GM, Kim JE, Smith CL, Huang GJ. Systematic review of self-ligating brackets. Am J Orthod Dentofacial Orthop. 2010 Jun;137(6):726.e1-726.e18; discussion 726-7. doi: 10.1016/j.ajodo.2009.11.009.

Reference Type RESULT
PMID: 20685517 (View on PubMed)

Garcia-Figueroa MA, Raboud DW, Lam EW, Heo G, Major PW. Effect of buccolingual root angulation on the mesiodistal angulation shown on panoramic radiographs. Am J Orthod Dentofacial Orthop. 2008 Jul;134(1):93-9. doi: 10.1016/j.ajodo.2006.07.034.

Reference Type RESULT
PMID: 18617108 (View on PubMed)

Lagravere MO, Carey J, Toogood RW, Major PW. Three-dimensional accuracy of measurements made with software on cone-beam computed tomography images. Am J Orthod Dentofacial Orthop. 2008 Jul;134(1):112-6. doi: 10.1016/j.ajodo.2006.08.024.

Reference Type RESULT
PMID: 18617110 (View on PubMed)

Morina E, Eliades T, Pandis N, Jager A, Bourauel C. Torque expression of self-ligating brackets compared with conventional metallic, ceramic, and plastic brackets. Eur J Orthod. 2008 Jun;30(3):233-8. doi: 10.1093/ejo/cjn005.

Reference Type RESULT
PMID: 18540011 (View on PubMed)

Sifakakis I, Pandis N, Makou M, Eliades T, Bourauel C. A comparative assessment of the forces and moments generated at the maxillary incisors between conventional and self-ligating brackets using a reverse curve of Spee NiTi archwire. Aust Orthod J. 2010 Nov;26(2):127-33.

Reference Type RESULT
PMID: 21175021 (View on PubMed)

Other Identifiers

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UDDS-Ortho-03-2016

Identifier Type: -

Identifier Source: org_study_id

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