Conventional versus 3D-printed twin block appliances: bacteria, surface texture, and effectiveness
Microbial Adherence, Surface Roughness, Effectiveness and Impact on Patients Between Conventional and 3D Printed Twin Block Appliances: An Open-Label Prospective Clinical Trial
NA · University of Malaya · NCT06944860
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 10 Years to 14 Years |
| Sex | All |
| Sponsor | University of Malaya (other) |
| Locations | 1 site (Kuala Lumpur, Kuala Lumpur) |
| Trial ID | NCT06944860 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Kuala Lumpur, Kuala Lumpur
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Orthodontic Appliances, Removable, Orthodontic Appliance Complication, Class II Malocclusion, Division 1, Twin block appliance, Microbial adherence, Surface roughness, Effectiveness, Oral Health Related Quality of Life