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A RCT to Compare OHRQoL Outcome for SLB and CB

Primary Purpose

Malocclusion

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Self-ligating brackets (SLB)
Conventional brackets (CB)
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring 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)

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Orthodontic Department of Mackay Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Self-ligating brackets

Conventional brackets

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Patient Reported Outcome - Oral Health Related Quality of Life

Secondary Outcome Measures

Pain

Full Information

First Posted
March 8, 2014
Last Updated
March 9, 2014
Sponsor
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02084277
Brief Title
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

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-ligating brackets
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional brackets
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Self-ligating brackets (SLB)
Other Intervention Name(s)
Damon Q
Intervention Type
Device
Intervention Name(s)
Conventional brackets (CB)
Other Intervention Name(s)
OPAK
Primary Outcome Measure Information:
Title
Patient Reported Outcome - Oral Health Related Quality of Life
Time Frame
one month
Secondary Outcome Measure Information:
Title
Pain
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tai-ting Lai, DrPH
Phone
+886-2-25433535
Ext
2216
Email
jadonis@mail2000.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tai-ting Lai, DrPH
Organizational Affiliation
Mackay Memorial Hospital,Taipei, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthodontic Department of Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tai-ting Lai, DrPH
Phone
+886-2-25433535
Ext
2216
Email
jadonis@mail2000.com.tw
First Name & Middle Initial & Last Name & Degree
Tai-ting Lai, DrPH

12. IPD Sharing Statement

Citations:
PubMed Identifier
10503795
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.
Results Reference
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PubMed Identifier
10783564
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.
Results Reference
background
PubMed Identifier
14560269
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.
Results Reference
background
PubMed Identifier
19852639
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.
Results Reference
background
PubMed Identifier
20123378
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.
Results Reference
background
PubMed Identifier
11683812
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.
Results Reference
background
PubMed Identifier
14994886
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.
Results Reference
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A RCT to Compare OHRQoL Outcome for SLB and CB

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