Microbial Adherence, Surface Roughness, Effectiveness and Impact on Patients Between Conventional and 3D Printed Twin Block Appliances: An Open-Label Prospective Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Malaya
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Microbial colony counts (CFU/ml) on the appliances.
Study Overview
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.
Detailed Description
RATIONALE OF STUDY
The rationale is to explore and address concerns related to the use of 3D printed resins with the Twin Block Appliance (TBA), in comparison to the conventional materials PMMA. The surface roughness of 3D printed resins, has been reported to be different from conventional materials and has been associated with increased microbial adhesion, particularly to Candida. This raises concerns about the potential oral health risks, such as dental caries and mucosal inflammation, when using 3D printed materials for orthodontic appliances.
Based on previous literature, it is postulated that bacterial load will be present on TBA surfaces, with the possibility of variation depending on the type of material used. This study aims to determine whether the microbial load decreases or increases based on the appliance material. Till date, there still remains a research gap specifically on microbial load in Twin Block appliances, making this study relevant in understanding the risks involved in the use of different materials in orthodontics.
Additionally, the study seeks to examine the effectiveness of 3D printed TBAs in reducing overjet and improving dental aesthetics, as well as the acceptability of these appliances by patients compared to conventional TBAs.
Furthermore, the study will compare the potential complications and treatment failures between conventional and 3D printed TBAs, aiming to demonstrate the practicality and feasibility of adopting 3D printing in the digital workflow for this appliance. By focusing on microbial adherence, surface roughness, treatment effectiveness, and oral health-related quality of life (OHRQoL), the study intends to provide valuable insights that could support the adoption of 3D printing technology in orthodontics while addressing the potential oral health risks associated with its use.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Investigator will be masked with the randomization sequance & allocation
Eligibility Criteria
- Ages
- 10 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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)
Arms & Interventions
Conventional Twin Block Appliance
Conventional TBA fabricated with polymethylmethacrylate (PMMA)
Intervention: Conventional TBA (Device)
3D Printed Twin Block Appliance
3D Twin Block Appliance fabricated with a 3D printing resin (TR07 Graphy)
Intervention: 3D TBA (Device)
Outcomes
Primary Outcomes
Microbial colony counts (CFU/ml) on the appliances.
Time Frame: 6 months
Microbial colony count on the conventional Twin Block appliance \& 3D printed Twin Block appliance The conventional Twin Block appliance (TBA) and the 3D printed Twin Block 3D TBA appliance that are collected from the patients before issue of the appliance (T0), after 3 months (T1) and at 6 months (T2). The TBA will be placed in BHI media and then will undergo the process of sonication, which will produce the bacteria suspension. This bacteria suspension will then be cultured in an agar plate with BHI media and incubated for 18 - 24 hours. The total colony per count will then be counted and recorded.
Assessment of Oral health-related quality of life (OHRQoL): PIDAQ Scores
Time Frame: 12 months
The Malaysian psychosocial impact of dental aesthetics (PIDAQ) questionnaire consists of 22 questions that measures the impact of malocclusion on the dental self-confidence (DSC), social impact (SI), psychological impact (PI) and aesthetic concern (AC). The responses to each question will be scored on a 5-point Likert scale and coded as follows: 0 = Not at all; 1 = A little; 2 = Somewhat; 3 = Strongly; 4 = Very strongly. The PIDAQ questionnaire will be distributed at T0 (at baseline- at issue appointment) T1 (at 3-months) TF (Final time-point).
Secondary Outcomes
- Surface roughness (Ra) of the appliances(6 months)
- Assessment of Oral health-related quality of life (OHRQoL): Child-ODIP (prevalence and scores)(12 months)
- Treatment effectiveness: Treatment duration (in months)(12 months)
- Treatment effectiveness: Linear measurements (in mm)(12 months)
- Frequency of the potential complications and treatment failures between the conventional Twin Block appliance and the 3D printed Twin Block appliances(12 months)
Investigators
Dr Wan Nurazreena Wan Hassan
Associate Professor, Department of Paediatric Dentistry & Orthodontics, Faculty of Dentistry Universiti Malaya
University of Malaya