Using lacebacks during braces alignment
Official title: Evaluation of Clinical and Patient-Reported Outcomes of Laceback: A Split-Mouth Randomised Controlled Trial
Run by International Islamic University Malaysia · NCT07039071 · Data updated 2026-11-12
This will see if using lacebacks on one side of the mouth helps patients aged 15 and older with fixed braces have better oral hygiene, fewer archwire problems, and different pain during the alignment phase.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 15 Years and up |
| Sex | All |
| Enrollment | 38 (estimated) |
| Sponsor | International Islamic University Malaysia Academic / other |
| Locations | 1 site (Kuantan, Pahang) |
| Status | Recruiting |
| Started | March 9, 2026 |
| Main results expected | June 2027 |
| Study ends | September 2027 |
| Registry record updated | May 13, 2026 |
| Trial ID | NCT07039071 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are medically fit orthodontic patients aged 15 or older with good baseline oral hygiene, full upper and lower fixed appliances to first molars, planned bilateral premolar extractions, and no prior orthodontic treatment.
✕Probably not a fit
Patients with craniofacial deformities, chronic medical or oral disease, impaired manual dexterity, or poor baseline oral hygiene were excluded and are unlikely to benefit from these findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a split-mouth randomized trial where each participant has one half of the mouth receive lacebacks while the other half does not, during the alignment phase of fixed appliance orthodontic treatment. Researchers will collect clinical measures of oral hygiene and plaque, record archwire and laceback complications, and gather patient-reported pain. The population includes medically fit orthodontic patients aged 15 and older undergoing full upper and lower fixed appliances with planned premolar extractions and no prior orthodontic treatment. All visits and treatments are conducted at the Department of Orthodontics at International Islamic University Malaysia during the alignment phase.
Why it matters
Potential benefit: If successful, using lacebacks could reduce archwire complications and improve oral hygiene and comfort during the alignment phase of fixed orthodontic treatment.
How similar studies have gone: Lacebacks are a traditional orthodontic technique with some clinical reports suggesting effects on tooth movement and appliance stability, but high-quality randomized split-mouth data on hygiene, complications, and pain are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Department of Orthodontics, Kulliyah of Dentistry, International Islamic University Malaysia
Kuantan, Pahang, Malaysia Recruiting
Study contacts
- Study coordinator: Dr. Tan Loon Han
- Email: tanloonhan@gmail.com
- Phone: +60123790908
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.