Clinical and Patient-Reported Outcomes of Laceback: A Protocol for Randomized Controlled Trial (Preprint)

BACKGROUND A laceback is a stainless-steel ligature commonly used during the leveling and alignment phase of fixed orthodontic treatment. It is tied in a figure-of-eight configuration, particularly in cases involving premolar extractions. Although lacebacks are thought to protect the flexible archwire from masticatory forces, their usage remains controversial, as current evidence is inconclusive. OBJECTIVE This study aims to assess the clinical and patient-reported outcomes of laceback usage during the alignment phase of orthodontic fixed appliance treatment. METHODS A single-center, split-mouth randomized controlled trial with a 1:1 allocation ratio for two groups. The left or right side of each subject’s oral cavity will be randomly assigned to receive laceback (LB), while the contralateral side will serve as the control (no LB). An estimated sample size of 38 subjects is needed for 76 sites (38 LB and 38 no LB). Four weeks and eight weeks after laceback placement, oral hygiene will be evaluated by recording the plaque score, number of archwire complications, and laceback complications. Pain levels will be assessed using a visual analogue scale. The primary outcome will be plaque score, and the secondary outcomes will include frequency of archwire and laceback complications and pain. A two-way repeated ANOVA test will be used to estimate differences in mean plaque score between the LB and no LB groups. A paired t-test will be used to compare differences in mean frequency of archwire complications between the LB and no LB groups. RESULTS This study will be funded in January 2026, and recruitment is planned between January 2026 and June 2027. No interim analyses have been performed; primary results are scheduled for Q4 2027. The manuscript is expected to be published by Q2 2028. CONCLUSIONS This randomized controlled trial will offer evidence-based recommendations to help clinicians weigh the risks and benefits of using lacebacks. This will support improvements in patients’ oral health and satisfaction while reducing treatment interruptions and resource wastage. CLINICALTRIAL ClinicalTrials.gov: NCT07039071