A RCT to Compare OHRQoL Outcome for SLB and CB

Malocclusion Clinical Trial

Official title:

A Randomized Clinical Trial to Compare Oral Health Related Quality of Life Outcome for Patients With Malocclusion Receiving Orthodontic Treatment: Before Treatment vs. During Initial Treatment; Self-ligating Brackets vs. Conventional Brackets

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02084277
• Other study ID #: 10MMHIS068
• Status: Recruiting
• Phase: N/A
• First received: March 8, 2014
• Last updated: March 9, 2014
• Start date: June 2010
• Est. completion date: December 2015

Study information

• Verified date: March 2014
• Source: Mackay Memorial Hospital
• Contact: Tai-ting Lai, DrPH
• Phone: +886-2-25433535
• Email: jadonis[@]mail2000.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The objective of this prospective study is to compare these two treatments (conventional brackets v.s. self-ligating brackets) in malocclusion to determine which treatment will provide the better oral health related quality of life (OHRQoL) outcomes for patients during the initial orthodontic treatment compared with pretreatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 40 Years

Eligibility

Inclusion Criteria:

• malocclusion patients

• age between 12 to 40 years

• suitable for orthodontic treatment using either self-ligating brackets or conventional brackets.

Exclusion Criteria:

• Any surgery performed in the previous days,

• Previous temporomandibular joint arthrotomies,

• Fewer than 20 teeth total or fewer than 10 teeth in each arch,

• Unstable residence or travel restrictions,

• Periodontal disease judged to be severe by the surgeon,

• Pregnancy,

• Previous mandibular surgery, and

• Inability to follow instructions or the study protocol.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malocclusion

Intervention

Device:
• Self-ligating brackets (SLB)

• Conventional brackets (CB)

Locations

Country	Name	City	State
Taiwan	Orthodontic Department of Mackay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (7)

Allen PF, McMillan AS, Walshaw D, Locker D. A comparison of the validity of generic- and disease-specific measures in the assessment of oral health-related quality of life. Community Dent Oral Epidemiol. 1999 Oct;27(5):344-52. — View Citation

Bergius M, Kiliaridis S, Berggren U. Pain in orthodontics. A review and discussion of the literature. J Orofac Orthop. 2000;61(2):125-37. Review. English, German. — View Citation

Cacciafesta V, Sfondrini MF, Ricciardi A, Scribante A, Klersy C, Auricchio F. Evaluation of friction of stainless steel and esthetic self-ligating brackets in various bracket-archwire combinations. Am J Orthod Dentofacial Orthop. 2003 Oct;124(4):395-402. — View Citation

Chen M, Wang DW, Wu LP. Fixed orthodontic appliance therapy and its impact on oral health-related quality of life in Chinese patients. Angle Orthod. 2010 Jan;80(1):49-53. doi: 10.2319/010509-9.1. — View Citation

Choi WS, Lee S, McGrath C, Samman N. Change in quality of life after combined orthodontic-surgical treatment of dentofacial deformities. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Jan;109(1):46-51. doi: 10.1016/j.tripleo.2009.08.019. — View Citation

Eberting JJ, Straja SR, Tuncay OC. Treatment time, outcome, and patient satisfaction comparisons of Damon and conventional brackets. Clin Orthod Res. 2001 Nov;4(4):228-34. — View Citation

Erdinç AM, Dinçer B. Perception of pain during orthodontic treatment with fixed appliances. Eur J Orthod. 2004 Feb;26(1):79-85. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Reported Outcome - Oral Health Related Quality of Life		one month	No
Secondary	Pain		one month	No