Clinical trial NCT02084277: A RCT to Compare OHRQoL Outcome for SLB and CB
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malocclusion
Keywords: Oral health-related quality of life (OHRQoL)
Self-ligating brackets (SLB)
Conventional brackets (CB)
Oral Health Impact Profile-14 (OHIP-14)
Short Form-36 (SF-36)
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient Reported Outcome - Oral Health Related Quality of Life
timeFrame: one month
Secondary outcomes:
measure: Pain
timeFrame: one month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Orthodontic Department of Mackay Memorial Hospital
Study officials:
affiliation: Mackay Memorial Hospital,Taipei, Taiwan
name: Tai-ting Lai, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1111/j.1600-0528.1999.tb02031.x.
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. doi: 10.1007/BF01300354. English, German.
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. doi: 10.1016/s0889-5406(03)00504-3.
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.
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.
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. doi: 10.1034/j.1600-0544.2001.40407.x.
citation: Erdinc AM, Dincer B. Perception of pain during orthodontic treatment with fixed appliances. Eur J Orthod. 2004 Feb;26(1):79-85. doi: 10.1093/ejo/26.1.79.