A RCT to Compare OHRQoL Outcome for SLB and CB

Mackay Memorial Hospital

Status: Unknown

Conditions: Malocclusion

Treatments: Device: Self-ligating brackets (SLB); Device: Conventional brackets (CB)

Study type: Interventional

Funder types: Other

Identifiers

NCT02084277

10MMHIS068

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

Self-ligating brackets

Experimental group

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.

Treatment:

Device: Self-ligating brackets (SLB)

Conventional brackets

Placebo Comparator group

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.

Treatment:

Device: Conventional brackets (CB)