Evaluation of Clinical and Patient-Reported Outcomes of Laceback: A Split-Mouth Randomised Controlled Trial

What this Trial Is About

Researchers are evaluating the clinical and patient-reported effects of using lacebacks during the alignment phase of orthodontic fixed appliance treatment for patients with malocclusion. The study aims to understand how lacebacks influence oral hygiene, the frequency of archwire and laceback complications, and pain experienced by patients. This trial uses a split-mouth design where one side of the mouth receives lacebacks and the other side does not, allowing direct comparison within each participant. Participants will receive standard braces, and one side of their mouth will be randomly assigned to have lacebacks placed on both upper and lower arches, while the other side will not. After braces placement, lacebacks are applied one week later, with baseline oral hygiene measured at that time. Participants continue usual oral hygiene practices while researchers monitor complications and pain over an 8-week period, collecting data at 4 and 8 weeks through plaque scoring, pain diaries, and records of any device issues. During the study, participants must report any suspected breakages or loose components for emergency visits. Pain levels are recorded at multiple time points using a pain diary with a visual scale. Researchers assess oral hygiene with the Orthodontic Plaque Index and track archwire and laceback complications throughout. The total participation includes initial placement, two follow-up visits at 4 and 8 weeks, and ongoing monitoring of symptoms and complications during this period.

Evaluation of Clinical and Patient-Reported Outcomes of Laceback