Evaluation of Clinical and Patient-Reported Outcomes of Laceback
Evaluation of Clinical and Patient-Reported Outcomes of Laceback: A Split-Mouth Randomised Controlled Trial
International Islamic University Malaysia
38 participants
Mar 9, 2026
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to evaluate oral hygiene status, archwire complications, laceback complications, and pain while using lacebacks in patients undergoing orthodontic fixed appliance treatment. The main questions it aims to answer are: 1. What is the effect of laceback on patient's oral hygiene during alignment phase of orthodontic fixed appliance treatment? 2. What is the effect of laceback on the frequency of archwire complications during alignment phase of orthodontic fixed appliance treatment? 3. What is the frequency of laceback complications during alignment phase of orthodontic fixed appliance treatment? 4. What is the effect of laceback on pain during alignment phase of orthodontic fixed appliance treatment? For each subject, researchers will randomly assign half of the oral cavity to receive laceback during orthodontic fixed appliance treatment, whereas the other half will not receive laceback. Researchers will then compare the effect of laceback on patient's oral hygiene, archwire complications, laceback complications, and pain. Participants are required to carry out the usual oral hygiene practices after braces and laceback are being put up. During the observation period, they are required to notify the researcher if they suspect any breakages or loose components, so that they come to the clinic for emergency appointments. They are also required to fill up a pain diary.
Eligibility
Inclusion Criteria9
- Patient factors
- Age 15 and above
- Medically fit and well
- Good oral hygiene - no dental caries, Basic Periodontal Examination (BPE) score 0
- Orthodontic factors
- Full upper and lower arch fixed orthodontic treatment (bonded till first permanent molars)
- Pre-adjusted edgewise appliance with 0.022" slot, MBT prescription, Master Series® brackets (American Orthodontics, USA)
- Extraction of bilateral upper and lower permanent first/second premolars
- No previous orthodontic treatment
Exclusion Criteria3
- Craniofacial deformities
- Mental or physical disability leading to impaired manual dexterity, difficulty in comprehending and following oral hygiene instructions
- Underlying chronic medical illness, oral diseases
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Interventions
Lacebacks are a kind of orthodontic auxilliaries used during the initial phase of orthodontic fixed appliance treatment, especially in premolar extraction cases. They are 0.010" stainless steel ligatures tied in figure-of-8 fashion beneath the main archwires, from the canine bracket till the first molar hook of one quadrant. For this study, on the side that is randomly allocated to receive laceback, laceback will be put on both upper and lower arches (from canine bracket to 1st molar hook).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07039071