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

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.

NCT Number	NCT06944860
Lead Sponsor	University of Malaya
Conditions	Orthodontic Appliances, Removable, Orthodontic Appliance Complication, Class II Malocclusion, Division 1
Enrollment	32 participants
Start Date	2025-05-01
Primary Completion	2026-01-17 (estimated)
Study Completion	2027-01-17 (estimated)
Updated on ClinicalTrials.gov	2025-06-18