A RCT to Compare OHRQoL Outcome for SLB and CB
Malocclusion
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
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
Experimental
Placebo Comparator
Self-ligating brackets
Conventional 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.
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.