Study Results
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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UNKNOWN
NA
120 participants
INTERVENTIONAL
2010-06-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Self-ligating brackets
Several self-ligating brackets are currently FDA-approved but have not been rigorously studied in this malocclusion patient population or in comparison to traditional brackets methods. Unlike conventional brackets, Self-ligating brackets (SLB) are bracket systems, without the wire ligature or elastic ligature, that have a tube-like device build into the bracket to close off the edgewise slot.
Self-ligating brackets (SLB)
Conventional brackets
The conventional brackets (CB) (edgewise appliance) retain the basic principle design of a rectangular wire in a rectangular slot. Archwire are tied to the bracket once placed in the slot with either elastometric ligation ties ("O-rings") or steel ligation.
Conventional brackets (CB)
Interventions
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Self-ligating brackets (SLB)
Conventional brackets (CB)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age between 12 to 40 years
* suitable for orthodontic treatment using either self-ligating brackets or conventional brackets.
Exclusion Criteria
* 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.
12 Years
40 Years
ALL
No
Sponsors
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Mackay Memorial Hospital
OTHER
Responsible Party
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Dr. Tai-ting Lai
Director of Orthodontic Department
Principal Investigators
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Tai-ting Lai, DrPH
Role: PRINCIPAL_INVESTIGATOR
Mackay Memorial Hospital,Taipei, Taiwan
Locations
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Orthodontic Department of Mackay Memorial Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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10MMHIS068
Identifier Type: -
Identifier Source: org_study_id
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