A RCT to Compare OHRQoL Outcome for SLB and CB

Not Applicable

• Conditions: Malocclusion
• Interventions: Device: Self-ligating brackets (SLB); Device: Conventional brackets (CB)

• Registration Number: NCT02084277
• Lead Sponsor: Mackay Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Status Verified: 2014-03
• Study First Submitted: 2014-03-08
• Study First Submitted QC: 2014-03-09
• Last Update Submitted: 2014-03-09
• Study First Posted: 2014-03-11
• Last Update Posted: 2014-03-11
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-ligating brackets	Self-ligating brackets (SLB)	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.
Conventional brackets	Conventional brackets (CB)	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.

Primary Outcome Measures

Name	Time	Method
Patient Reported Outcome - Oral Health Related Quality of Life	one month

Secondary Outcome Measures

Name	Time	Method
Pain	one month

Trial Locations

Locations (1)

Orthodontic Department of Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan