Treatment of Crowding Without Extraction Using Self Ligating Brackets

Crowding Clinical Trial

Official title:

Assessment of Dentoalveolar Changes Resulting From Orthodontic Treatment of Crowding With Self-ligating Brackets Using CBCT Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996292
• Other study ID #: UDDS-Ortho-03-2016
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: July 19, 2018

Study information

• Verified date: July 2018
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 19, 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crowding

Intervention

Device:
• Traditional brackets
Treating of crowding using traditional brackets
• Active self-ligating brackets
Treating of crowding using active self-ligating brackets
• Passive self-ligating brackets
Treating of crowding using passive self-ligating brackets

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus University	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Lagravère 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. — View Citation

Morina E, Eliades T, Pandis N, Jäger 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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speed of alignment	Speed of alignment will be measured and compared between the groups.	After 9 months
Secondary	Changes of the torque and tipping of teeth	The torque and tipping of teeth will be evaluated before and after treatment and compared between the groups using CBCT images.	Evaluation before and after alignment and leveling teeth. (after 9 months)
Secondary	Changes of widths and depths of the dental arches	Changes of dental arches dimensions will be measured and compared between groups.	Evaluation before and after alignment and leveling teeth. (after 9 months)
Secondary	External apical root resorption	External apical root resorption of each tooth on CBCT images (frequencies) after treatment.	After 9 months