Microbial Adherence, Surface Roughness, Effectiveness and Impact on Patients Between Conventional and 3D Printed Twin Block Appliances
Recruiting now · Not applicable
Conditions studied: Orthodontic Appliances, Removable, Orthodontic Appliance Complication, Class II Malocclusion, Division 1
In brief
The Twin Block appliance is a removable orthodontic appliance that is used to help correct a backward positioned lower jaw in growing children. This appliance works by guiding the lower jaw forward to a specific position over a certain period of time. After completing the treatment, patients often experience improvements in their appearance, such as an improved bite, a more balanced facial profile and improved lip posture. The investigators' interest is to compare two types of Twin Block appliances; traditional (conventional) and 3D-printed, by examining several factors, including the amount of bacteria that stick to them, the surface roughness, and the overall effectiveness of each type. Surface roughness refers to the texture of the appliance's surface, which could influence how much bacteria can accumulate. Rougher surfaces may trap more bacteria, potentially leading to oral health issues such as bad breath, tooth decay, and gum problems. The study will also assess the effectiveness of both the conventional and 3D-printed Twin Block appliances, focusing on factors like how well they perform in improving jaw position and achieving the desired treatment outcomes. Additionally, the investigators want to assess how these appliances affect the quality of life related to oral health. Participants will answer questions about their experience to help understand how the type of appliance impacts their daily lives, comfort, and overall well-being during the course of treatment.
Key facts
- Study ID
- NCT06944860
- Run by
- University of Malaya
- People needed
- 32
- Starts
- 2025-05-01
- Expected to finish
- 2027-01-17
- Last updated by the study team
- 2025-06-18
Who can join
Age: 10 and older, up to 14. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with Class II Division 1 incisor relationship
- Overjet of ≥ 7mm
- Age range of children: 10-12 years in females, 12-14 years in males
- All permanent incisors and molars erupted
- ICDAS ≥ score 3 and BPE ≥ 3
- Able to understand English or Bahasa Melayu
You may not qualify if…
- Patients with craniofacial syndromes (example: cleft lip and palate)
- Patients with previous history of orthodontic treatment
- Patients with hyperdivergent facial type (MMPA > 40º)
- Untreated gingival disease (e.g.: gingivitis, periodontitis)
Where it is running
- Orthodontic Postgraduate Clinic, Faculty of Dentistry, Universiti Malaya — Kuala Lumpur, Kuala Lumpur, Malaysia (enrolling)
Full record on ClinicalTrials.gov
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