A RCT to Compare OHRQoL Outcome for SLB and CB

NCT ID: NCT02084277

Last Updated: 2014-03-11

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Self-ligating brackets (SLB)

Intervention Type DEVICE

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.

Group Type PLACEBO_COMPARATOR

Conventional brackets (CB)

Intervention Type DEVICE

Interventions

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Self-ligating brackets (SLB)

Intervention Type DEVICE

Conventional brackets (CB)

Intervention Type DEVICE

Other Intervention Names

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Damon Q OPAK

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mackay Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Tai-ting Lai

Director of Orthodontic Department

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Tai-ting Lai, DrPH

Role: CONTACT

+886-2-25433535 ext. 2216

Facility Contacts

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Tai-ting Lai, DrPH

Role: primary

+886-2-25433535 ext. 2216

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.

Reference Type BACKGROUND
PMID: 10503795 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10783564 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14560269 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19852639 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20123378 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11683812 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14994886 (View on PubMed)

Other Identifiers

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10MMHIS068

Identifier Type: -

Identifier Source: org_study_id

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