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

NCT06944860 | Recruiting

• 3 other identifiers: S2106613/2IIRG002-2022HWBUMG034E-2025
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthodontic Appliances, Removable; Orthodontic Appliance Complication; Class II Malocclusion, Division 1

Keywords

Twin block appliance; Microbial adherence; Surface roughness; Effectiveness; Oral Health Related Quality of Life (OHRQoL)

Outcome Measures

Primary Outcomes (2)

• Microbial colony counts (CFU/ml) on the appliances.

  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.

  6 months

• Assessment of Oral health-related quality of life (OHRQoL): PIDAQ Scores

  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).

  12 months

Secondary Outcomes (5)

• 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

Study Arms (2)

Conventional Twin Block Appliance

ACTIVE COMPARATOR

Conventional TBA fabricated with polymethylmethacrylate (PMMA)

Device: Conventional TBA

3D Printed Twin Block Appliance

EXPERIMENTAL

3D Twin Block Appliance fabricated with a 3D printing resin (TR07 Graphy)

Device: 3D TBA

Interventions

Conventional TBA DEVICE

Conventional TBA fabricated with polymethylmethacrylate

Conventional Twin Block Appliance

3D TBA DEVICE

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

3D Printed Twin Block Appliance

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Orthodontic Postgraduate Clinic, Faculty of Dentistry, Universiti Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

RECRUITING

Related Publications (11)

• Yusuf H, Gherunpong S, Sheiham A, Tsakos G. Validation of an English version of the Child-OIDP index, an oral health-related quality of life measure for children. Health Qual Life Outcomes. 2006 Jul 1;4:38. doi: 10.1186/1477-7525-4-38.

  PMID: 16813660 BACKGROUND

• Marsh PD. Dental plaque as a biofilm and a microbial community - implications for health and disease. BMC Oral Health. 2006 Jun 15;6 Suppl 1(Suppl 1):S14. doi: 10.1186/1472-6831-6-S1-S14.

  PMID: 16934115 BACKGROUND

• Klages U, Claus N, Wehrbein H, Zentner A. Development of a questionnaire for assessment of the psychosocial impact of dental aesthetics in young adults. Eur J Orthod. 2006 Apr;28(2):103-11. doi: 10.1093/ejo/cji083. Epub 2005 Oct 28.

  PMID: 16257989 BACKGROUND

• Graf S, Tarraf NE, Vasudavan S. Direct printed removable appliances: A new approach for the Twin-block appliance. Am J Orthod Dentofacial Orthop. 2022 Jul;162(1):103-107. doi: 10.1016/j.ajodo.2021.08.019.

  PMID: 35772870 BACKGROUND

• El-Huni A, Colonio Salazar FB, Sharma PK, Fleming PS. Understanding factors influencing compliance with removable functional appliances: A qualitative study. Am J Orthod Dentofacial Orthop. 2019 Feb;155(2):173-181. doi: 10.1016/j.ajodo.2018.06.011.

  PMID: 30712688 BACKGROUND

• Mohd Tahir N, Wan Hassan WN, Saub R. Comparing retainers constructed on conventional stone models and on 3D printed models: a randomized crossover clinical study. Eur J Orthod. 2019 Aug 8;41(4):370-380. doi: 10.1093/ejo/cjy063.

  PMID: 30321319 BACKGROUND

• Yacob N, Ahmad NA, Safii SH, Yunus N, Abdul Razak F. Is microbial adhesion affected by the build orientation of a 3-dimensionally printed denture base resin? J Prosthet Dent. 2023 Jul;130(1):131.e1-131.e7. doi: 10.1016/j.prosdent.2023.04.017. Epub 2023 May 19.

  PMID: 37210224 BACKGROUND

• Wuersching SN, Westphal D, Stawarczyk B, Edelhoff D, Kollmuss M. Surface properties and initial bacterial biofilm growth on 3D-printed oral appliances: a comparative in vitro study. Clin Oral Investig. 2023 Jun;27(6):2667-2677. doi: 10.1007/s00784-022-04838-7. Epub 2022 Dec 28.

  PMID: 36576565 BACKGROUND

• Belayutham S, Wan Hassan WN, Razak FA, Mohd Tahir NNZ. Microbial adherence on vacuum-formed retainers with different surface roughness as constructed from conventional stone models and 3D printed models: a randomized controlled clinical trial. Clin Oral Investig. 2023 Jun;27(6):3245-3259. doi: 10.1007/s00784-023-04940-4. Epub 2023 Mar 22.

  PMID: 36947263 BACKGROUND

• Pacha MM, Fleming PS, Pandis N, Shagmani M, Johal A. The use of the Hanks Herbst vs Twin-block in Class II malocclusion: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2023 Sep;164(3):314-324.e1. doi: 10.1016/j.ajodo.2023.06.002. Epub 2023 Jul 4.

  PMID: 37409988 BACKGROUND

• Farhadian N, Usefi Mashoof R, Khanizadeh S, Ghaderi E, Farhadian M, Miresmaeili A. Streptococcus mutans counts in patients wearing removable retainers with silver nanoparticles vs those wearing conventional retainers: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2016 Feb;149(2):155-60. doi: 10.1016/j.ajodo.2015.07.031.

  PMID: 26827971 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Roselyn Mathew

CONTACT

+60173144323; roselynmathew89@gmail.com

Wan Nurazreena Wan Hassan

CONTACT

+60379674802; wannurazreena@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Investigator will be masked with the randomization sequance \& allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Paediatric Dentistry & Orthodontics, Faculty of Dentistry Universiti Malaya

Model Details: Baseline characteristics - newly constructed conventional Twin Block appliances and 3D printed Twin Block appliances will be tested for microbial analysis, surface roughness, effectiveness and the impact on the patient's quality of life Group 1 - Participants with Conventional Twin Block appliance Group 2 - Participants with 3D printed Twin Block appliance

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 25, 2025
• Study Start: May 1, 2025
• Primary Completion: January 17, 2026
• Study Completion (Estimated): January 17, 2027
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)