Clinical and Patient-Reported Outcomes of Laceback Ligature in Fixed Orthodontic Treatment: Protocol for a Randomized Controlled Trial.

Background: Laceback ligatures are passive stainless-steel auxiliaries tied from the first permanent molar hook to the canine bracket during the alignment phase of orthodontic fixed appliance treatment, predominantly in premolar extraction cases. Despite equivocal evidence on their effectiveness in controlling anterior tooth position, lacebacks are routinely used to stabilize flexible nickel-titanium archwires against masticatory forces. Their effects on 3 clinically important outcomes, oral hygiene, appliance complication rates, and patient-reported pain, have never been investigated in a randomized trial, representing gaps explicitly identified in a prior systematic review. Objective: This study aims to evaluate the clinical and patient-reported outcomes of passive laceback ligatures during the alignment phase of orthodontic fixed appliance treatment, specifically oral hygiene status, archwire and laceback complication rates, and pain. Methods: This is a single-center, single-blind, split-mouth randomized controlled trial conducted at the Orthodontic Clinic, International Islamic University Malaysia. Eligible participants are patients aged 15 years and older, medically fit with Basic Periodontal Examination scores of 0-2, requiring full fixed appliance treatment with bilateral premolar extractions and no prior orthodontic treatment. Those with craniofacial deformities, systemic illness, or disability affecting oral hygiene compliance are excluded. Each participant's oral cavity is randomly allocated using a minimization method, so that one side receives a passive 0.010-inch stainless-steel laceback from the first molar hook to the canine bracket, while the contralateral side receives identical standard fixed appliance treatment (McLaughlin, Bennett, and Trevisi prescription brackets, 0.014-inch superelastic nickel-titanium archwires, and elastomeric modules) without laceback. Outcomes are assessed at baseline (T0), 4 weeks (T1), and 8 weeks (T2) after laceback placement. The primary outcome is the orthodontic plaque index. Secondary outcomes include archwire and laceback complication frequencies and pain assessed by visual analog scale area under the curve. A total of 38 participants provided 85% power to detect a 1-unit orthodontic plaque index difference (α=.05). Mixed-model repeated-measures analysis is applied to plaque scores; paired parametric or nonparametric tests to other outcomes. Plaque and archwire assessors are blinded to treatment allocation. Results: Ethical approval and funding were secured in January 2026. Participant recruitment commenced in February 2026 with a target completion of June 2027. Pretrial examiner calibration achieved satisfactory agreement (interrater Cohen kappa=0.801-0.804; intrarater reliability=0.806-0.862). As of paper submission, 24 participants have been enrolled, and 14 have completed all data collection visits, with no protocol deviations recorded. Primary analysis is scheduled for October 2027; the results are targeted for submission by June 2028. Conclusions: This protocol describes the first randomized controlled trial to simultaneously evaluate oral hygiene, appliance complication rates, and patient-reported pain associated with laceback use during orthodontic alignment. The split-mouth design controls for interparticipant confounders, and the incorporation of patient-reported outcomes will ensure that findings directly support evidence-based, patient-centered orthodontic practice.