Actively Recruiting
Evaluation of Clinical and Patient-Reported Outcomes of Laceback
Led by International Islamic University Malaysia · Updated on 2026-05-13
38
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Clinical and Patient-Reported Outcomes of Laceback
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 15 and above
- Medically fit and well
- Good oral hygiene with no dental caries and Basic Periodontal Examination score 0
- Undergoing full upper and lower arch fixed orthodontic treatment bonded to first permanent molars
- Using pre-adjusted edgewise appliance with 0.022" slot, MBT prescription, Master Series�ae brackets
- Extraction of bilateral upper and lower first or second permanent premolars
- No previous orthodontic treatment
You will not qualify if you...
- Craniofacial deformities
- Mental or physical disability causing impaired manual dexterity or difficulty following oral hygiene instructions
- Underlying chronic medical illness or oral diseases
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Orthodontics, Kulliyah of Dentistry, International Islamic University Malaysia
Kuantan, Pahang, Malaysia, 25200
Actively Recruiting
Research Team
D
Dr. Tan Loon Han
CONTACT
A
Assistant Professor Dr. Siti Hajjar Binti Nasir
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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