Conventional versus 3D-printed twin block appliances: bacteria, surface texture, and effectiveness
Official title: Microbial Adherence, Surface Roughness, Effectiveness and Impact on Patients Between Conventional and 3D Printed Twin Block Appliances: An Open-Label Prospective Clinical Trial
Run by University of Malaya · NCT06944860 · Data updated 2026-11-12
This trial will test whether 3D-printed twin block appliances work as well as conventional ones and whether they attract more bacteria or have rougher surfaces in growing children with Class II Division 1 malocclusion.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 10 Years to 14 Years |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | University of Malaya Academic / other |
| Locations | 1 site (Kuala Lumpur, Kuala Lumpur) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | January 17, 2026 |
| Study ends | January 17, 2027 |
| Registry record updated | June 18, 2025 |
| Trial ID | NCT06944860 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children with Class II Division 1 incisor relationship, overjet ≥ 7 mm, all permanent incisors and molars erupted, aged about 10–12 years for girls and 12–14 years for boys, and able to understand English or Bahasa Melayu.
✕Probably not a fit
Patients with craniofacial syndromes, previous orthodontic treatment, hyperdivergent facial type, untreated gingival disease, or those outside the specified age/eruption criteria are unlikely to benefit or qualify.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Children who meet the age and dental criteria will receive either a conventional acrylic twin block or a 3D-printed twin block appliance. The study will compare microbial adherence (including bacterial and fungal load), measure material surface roughness, and track clinical outcomes such as overjet reduction and oral-health–related quality of life. Appliance surfaces will be sampled and analyzed microbiologically and examined for roughness while clinicians record complications, treatment failures, and patient acceptability. Findings will indicate whether 3D-printed materials perform similarly to conventional PMMA for twin block therapy.
Why it matters
Potential benefit: If successful, this could identify a 3D-printed option that is as effective as conventional appliances but with similar or lower bacterial buildup and good patient acceptance.
How similar studies have gone: Some studies on other 3D-printed orthodontic materials have reported different surface roughness and increased microbial adhesion compared with PMMA, but direct evidence specific to twin block appliances is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with Class II Division 1 incisor relationship 2. Overjet of ≥ 7mm 3. Age range of children: 10-12 years in females, 12-14 years in males 4. All permanent incisors and molars erupted 5. ICDAS ≥ score 3 and BPE ≥ 3 6. Able to understand English or Bahasa Melayu Exclusion Criteria: 1. Patients with craniofacial syndromes (example: cleft lip and palate) 2. Patients with previous history of orthodontic treatment 3. Patients with hyperdivergent facial type (MMPA \> 40º) 4. Untreated gingival disease (e.g.: gingivitis, periodontitis)
Where it's running
-
Orthodontic Postgraduate Clinic, Faculty of Dentistry, Universiti Malaya
Kuala Lumpur, Kuala Lumpur, Malaysia Recruiting
Study contacts
- Study coordinator: Roselyn Mathew
- Email: roselynmathew89@gmail.com
- Phone: +60173144323
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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.