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Microbial Adherence, Surface Roughness, Effectiveness and Impact on Patients Between Conventional and 3D Printed Twin Block Appliances

RecruitingNAAges 10 Years - 14 YearsAllUniversity of Malaya
NCT06944860 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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)
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What it tests

  • Conventional TBA
  • 3D TBA
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Where

1 site
Orthodontic Postgraduate Clinic, Faculty of Dentistry, Universiti Malaya
Kuala Lumpur, Malaysia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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