RecruitingNot ApplicableNCT06944860

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

Microbial Adherence, Surface Roughness, Effectiveness and Impact on Patients Between Conventional and 3D Printed Twin Block Appliances: An Open-Label Prospective Clinical Trial


Sponsor

University of Malaya

Enrollment

32 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 10 YearsMax Age: 14 Years

Inclusion Criteria6

  • 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

Exclusion Criteria4

  • 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)

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Interventions

DEVICEConventional TBA

Conventional TBA fabricated with polymethylmethacrylate

DEVICE3D TBA

3D TBA made out of a 3D printing resin (Graphy TR07)


Locations(1)

Orthodontic Postgraduate Clinic, Faculty of Dentistry, Universiti Malaya

Kuala Lumpur, Kuala Lumpur, Malaysia

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NCT06944860


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