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Evaluation of Clinical and Patient-Reported Outcomes of Laceback

RecruitingNAAges 15 Years - anyAllInternational Islamic University Malaysia
NCT07039071 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 oth

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📋 Eligibility rules (as published)
Inclusion Criteria: 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 Criteria: * 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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What it tests

  • Laceback
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Where

1 site
Department of Orthodontics, Kulliyah of Dentistry, International Islamic University Malaysia
Kuantan, Malaysia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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