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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02084277

Enrollment

120

Registered

2014-03-11

Start date

2010-06-30

Completion date

2015-12-31

Last updated

2014-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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)

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.

Interventions

DEVICESelf-ligating brackets (SLB)

DEVICEConventional brackets (CB)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 40 Years

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.

Design outcomes

Primary

Measure	Time frame
Patient Reported Outcome - Oral Health Related Quality of Life	one month

Secondary

Measure	Time frame
Pain	one month

Countries

Taiwan

Contacts

Primary ContactTai-ting Lai, DrPH

jadonis@mail2000.com.tw+886-2-25433535

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026