NCT07039071 Evaluation of Clinical and Patient-Reported Outcomes of Laceback
| NCT ID | NCT07039071 |
| Status | Recruiting |
| Phase | — |
| Sponsor | International Islamic University Malaysia |
| Condition | Malocclusion |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2026-03-09 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 38 participants in total. It began in 2026-03-09 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Assistant Professor Dr. Siti Hajjar Binti Nasir
STUDY CHAIR
International Islamic University Malaysia
Frequently Asked Questions
Who can join the NCT07039071 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying Malocclusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07039071 currently recruiting?
Yes, NCT07039071 is actively recruiting participants. Contact the research team at tanloonhan@gmail.com for enrollment information.
Where is the NCT07039071 trial being conducted?
This trial is being conducted at Kuantan, Malaysia.
Who is sponsoring the NCT07039071 clinical trial?
NCT07039071 is sponsored by International Islamic University Malaysia. The principal investigator is Assistant Professor Dr. Siti Hajjar Binti Nasir at International Islamic University Malaysia. The trial plans to enroll 38 participants.