NCT06944860 Microbial Adherence, Surface Roughness, Effectiveness and Impact on Patients Between Conventional and 3D Printed Twin Block Appliances
| NCT ID | NCT06944860 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Malaya |
| Condition | Orthodontic Appliances, Removable |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2026-01-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2025-05-01 with a primary completion date of 2026-01-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06944860 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 14 Years, studying Orthodontic Appliances, Removable. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06944860 currently recruiting?
Yes, NCT06944860 is actively recruiting participants. Contact the research team at roselynmathew89@gmail.com for enrollment information.
Where is the NCT06944860 trial being conducted?
This trial is being conducted at Kuala Lumpur, Malaysia.
Who is sponsoring the NCT06944860 clinical trial?
NCT06944860 is sponsored by University of Malaya. The trial plans to enroll 32 participants.