A RCT to Compare OHRQoL Outcome for SLB and CB
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
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 8, 2014
CompletedFirst Posted
Study publicly available on registry
March 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 11, 2014
March 1, 2014
5.5 years
March 8, 2014
March 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Reported Outcome - Oral Health Related Quality of Life
one month
Secondary Outcomes (1)
Pain
one month
Study Arms (2)
Self-ligating brackets
EXPERIMENTALSeveral 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.
Conventional brackets
PLACEBO COMPARATORThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- malocclusion patients
- age between 12 to 40 years
- suitable for orthodontic treatment using either self-ligating brackets or conventional brackets.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orthodontic Department of Mackay Memorial Hospital
Taipei, 10449, Taiwan
Related 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. doi: 10.1111/j.1600-0528.1999.tb02031.x.
PMID: 10503795BACKGROUNDBergius 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.
PMID: 10783564BACKGROUNDCacciafesta 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.
PMID: 14560269BACKGROUNDChen 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.
PMID: 19852639BACKGROUNDChoi 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.
PMID: 20123378BACKGROUNDEberting 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.
PMID: 11683812BACKGROUNDErdinc 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.
PMID: 14994886BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tai-ting Lai, DrPH
Mackay Memorial Hospital,Taipei, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Orthodontic Department
Study Record Dates
First Submitted
March 8, 2014
First Posted
March 11, 2014
Study Start
June 1, 2010
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
March 11, 2014
Record last verified: 2014-03