Treatment of Crowding Without Extraction Using Self Ligating Brackets

NCT02996292 | Completed DMC

• 1 other identifier: UDDS-Ortho-03-2016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crowding

Keywords

Crowding; Self ligating; CBCT; RCT

Outcome Measures

Primary Outcomes (1)

• Speed of alignment

  Speed of alignment will be measured and compared between the groups.

  After 9 months

Secondary Outcomes (3)

• Changes of the torque and tipping of teeth

  Evaluation before and after alignment and leveling teeth. (after 9 months)

• Changes of widths and depths of the dental arches

  Evaluation before and after alignment and leveling teeth. (after 9 months)

• External apical root resorption

  After 9 months

Study Arms (3)

Traditional brackets

EXPERIMENTAL

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

Device: Traditional brackets

Active self-ligating brackets

EXPERIMENTAL

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"

Device: Active self-ligating brackets

Passive self-ligating brackets

EXPERIMENTAL

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"

Device: Passive self-ligating brackets

Interventions

Traditional brackets DEVICE

Treating of crowding using traditional brackets

Traditional brackets

Active self-ligating brackets DEVICE

Treating of crowding using active self-ligating brackets

Active self-ligating brackets

Passive self-ligating brackets DEVICE

Treating of crowding using passive self-ligating brackets

Passive self-ligating brackets

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, Syria

Location

Related Publications (7)

• 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.

  PMID: 18456146 RESULT

• 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.

  PMID: 15056110 RESULT

• 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.

  PMID: 20685517 RESULT

• 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.

  PMID: 18617108 RESULT

• 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.

  PMID: 18617110 RESULT

• 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.

  PMID: 18540011 RESULT

• 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.

  PMID: 21175021 RESULT

MeSH Terms

Conditions

Crowding

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior

Study Officials

• Ahmad S Burhan, PhD.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 19, 2016
• Study Start: September 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: July 19, 2018
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)