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| ID | Type | Description | Link |
|---|---|---|---|
| JEP 2025-630 | Other Identifier | National university of Malaysia |
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| Name | Class |
|---|---|
| University of Malaya | OTHER |
| Universiti Teknologi Mara | OTHER |
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Expansion of the arches is generally considered highly unstable and prone to relapse regardless of the type of expansion. Retention appliances play a vital role in preserving these changes. Hawley retainer users often avoid wearing them due to speech difficulties and less aesthetic appeal. They are also more prone to breakage, costlier, and require more labour. Despite the relatively recent introduction of 3D-printed retainers, they offer potential advantages in orthodontics, including the accuracy of digitally scanned images, reduced labour and material costs, and improved patient comfort. While 3D-printed retainers are quite new, most studies focus on laboratory testing of their mechanical properties, there is limited evidence directly comparing their effectiveness in retaining arch width increases, patient acceptance, and cost estimation. This knowledge gap creates uncertainty about the optimal choice of retainer for long-term stability, necessitating a comparative assessment of their performance. This study addresses this knowledge gap by evaluating the retention of arch width increases achieved using Hawley retainers versus 3D-printed retainers
Maxillary dentoalveolar expansion is a procedure to correct transverse discrepancies between the maxillary and mandibular arches by applying forces to widen the maxillary arch. This procedure is inherently unstable and is susceptible to relapse. While Hawley retainers (HR) have served as the established standard for retention after maxillary expansion, recent studies have shown that modified thermoforming retainers can be as effective as HR. The emergence of computer-aided design and computer-aided manufacturing (CAD-CAM) and three-dimensional (3D) printing technology has significantly streamlined fabricating appliances and prostheses. 3D printing material is more rigid, with superior compression and tensile strength. Thus, a normal shape 3D-printed retainer may be a viable choice for the retention of maxillary expansion. A recent systematic review highlighted a critical gap in knowledge regarding the long-term clinical efficacy and durability of 3D-printed retainers. Thus, the present study aimed to address this research gap by investigating the long-term clinical effectiveness, patient acceptance, and cost estimation of 3D-printed retainers in expansion cases. This study will be carried out as a multicentre prospective randomized controlled clinical trial (RCT) conducted at Universiti Kebangsaan Malaysia (UKM), Universiti Malaya (UM), and Universiti Teknologi MARA (UiTM). Orthodontic patients who fulfil the inclusion criteria will be randomly allocated into the HR or 3D-printed retainer groups. Dental casts of patients will be measured at intercanine width (ICW), inter-premolar width (IPMW), inter-first molar mesiobuccal cusp width 1 (IFMW1), and inter-first molar distobuccal cusp width 2 (IFMW2) for both groups at debond(T0), 3(T1), 6(T2), and 12(T3). The outcome assessor and data analyst will be blinded to the retention method. The researcher will evaluate the patient's acceptance at T2 & T3 and conduct a cost analysis at T1 post-debond. The findings of this study will contribute valuable data to the field of orthodontics, aiding clinicians in determining the most effective long-term retention strategy for patients who have undergone maxillary dentoalveolar expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hawley retainer | Active Comparator | A screening will be done to select suitable patients for the study. Only patients who fulfil the criteria will be invited to participate in this study. Following informed consent, eligible subjects will be randomly allocated into one of two groups wither hawley retainer or 3D printed retainer. Fabrication of Hawley retainers will be done using a standardized design across all centres. |
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| 3D printed retainer | Experimental | A screening will be done to select suitable patients for the study. Only patients who fulfil the criteria will be invited to participate in this study. Following informed consent, eligible subjects will be randomly allocated into one of two groups wither hawley retainer or 3D printed retainer. Fabrication of 3d printed retainers will be done using a standardized design at one main centres by one technician using Nextdent Orhtoflex Resin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D printed retainer | Device | 3D-printed retainer Using Nextdent Orthoflex resin Standard design of 3D printed retainer:
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| Measure | Description | Time Frame |
|---|---|---|
| Retention of the maxillary expansion |
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient acceptance | Subjects will be given and asked to complete a questionnaire on patient acceptance (see attachment) at 6 and 12 months post-debond. The Questionnaire has been validated and published by (Saw et al. 2025). It uses a Visual Analogue Scale (VAS) to ask six questions related to subject acceptance of orthodontic retainers in fitting, speech, appearance, oral hygiene, durability, and comfort. Refer to Attachment 1 (Malay version) and Attachment 2 (English Version) for the questionnaires. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asma Ashari, BDS Adel, MClinDent Lon, MOrth | Contact | +603 8921 5555 | asmaashari@ukm.edu.my | |
| ALIZAE MARNY FADZLIN SYED MOHAMED | Contact | +6038921 5555 | alizaemarny@ukm.edu.my |
| Name | Affiliation | Role |
|---|---|---|
| Asma Ashari, MClinDent Lon | National University of Malaysia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Of Malaysia | Kuala Lumpur | Kuala Lumpur | 50300 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35565167 | Background | Firlej M, Zaborowicz K, Zaborowicz M, Firlej E, Domagala I, Pieniak D, Igielska-Kalwat J, Dmowski A, Biedziak B. Mechanical Properties of 3D Printed Orthodontic Retainers. Int J Environ Res Public Health. 2022 May 9;19(9):5775. doi: 10.3390/ijerph19095775. | |
| 17702797 | Background | Hichens L, Rowland H, Williams A, Hollinghurst S, Ewings P, Clark S, Ireland A, Sandy J. Cost-effectiveness and patient satisfaction: Hawley and vacuum-formed retainers. Eur J Orthod. 2007 Aug;29(4):372-8. doi: 10.1093/ejo/cjm039. |
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Only data relevant to the study analyses will be provided. All personal identifiers and information that could reveal participant identity will be removed to protect confidentiality and comply with ethical requirements.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2026 |
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This study will be a multicentre prospective randomized controlled clinical trial conducted at Universiti Kebangsaan Malaysia (UKM), Universiti Malaya (UM), and Universiti Teknologi MARA (UiTM). A screening will be done to select suitable patients for the study. Only patients who fulfil the criteria will be invited to participate in this study. Participants will be approached in the dental chair once deemed suitable and given 5-10 minutes to decide on study participation. Consent will be gathered from the patients or the carer if the patient is below 18. Following informed consent, eligible subjects will be randomly allocated into one of two groups:
Group 1: Hawley retainer. Group 2: 3D-printed retainer Dental casts of patients will be measured at intercanine width (ICW), inter-premolar width (IPMW), inter-first molar mesiobuccal cusp width 1 (IFMW1), and inter-first molar distobuccal cusp width 2 (IFMW2) for both groups at debond(T0), 3 (T1), 6(T2), and 12months(T3).
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Investigators know who the participants are but will keep that information hidden from everyone else. Investigators will anonymize personally identifiable data so that it cannot be linked to other data by anyone else. Physical, social, psychological, and all other types of harm are kept to an absolute minimum.
| Hawley retainer | Device | Hawley retainers have served as the established standard for retention after maxillary expansion. Standard design of Hawley Retainer: - Labial bow (0.8mm hard stainless steel) from canine to canine - Adam clasp on the molar (0.7mm hard stainless steel) - acrylic baseplate (2-3mm thickness) . |
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| 12 months |
| cost estimation | To estimate and compare the costs associated with the implementation and provision of 3D-printed retainers between clinics with existing in-house 3D-printing facilities and clinics planning to acquire 3D-printing services. The analysis will include direct costs such as equipment acquisition, materials, software, maintenance, laboratory procedures, and staff chairside time. | 6 months |
| University Malaya | Kuala Lumpur | Kuala Lumpur | 50603 | Malaysia |
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| University Teknologi Mara Selangor branch | Sungai Buloh | Selangor | 47000 | Malaysia |
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| 35337648 | Background | Naeem OA, Bencharit S, Yang IH, Stilianoudakis SC, Carrico C, Tufekci E. Comparison of 3-dimensional printing technologies on the precision, trueness, and accuracy of printed retainers. Am J Orthod Dentofacial Orthop. 2022 Apr;161(4):582-591. doi: 10.1016/j.ajodo.2021.03.016. |
| 37189925 | Background | Tsoukala E, Lyros I, Tsolakis AI, Maroulakos MP, Tsolakis IA. Direct 3D-Printed Orthodontic Retainers. A Systematic Review. Children (Basel). 2023 Apr 3;10(4):676. doi: 10.3390/children10040676. |
| 39752631 | Background | Saw ZK, Yuen JJX, Ashari A, Ibrahim Bahemia F, Low YX, Nik Mustapha NM, Lau MN. Forward-backward translation, content validity, face validity, construct validity, criterion validity, test-retest reliability, and internal consistency of a questionnaire on patient acceptance of orthodontic retainer. PLoS One. 2025 Jan 3;20(1):e0314853. doi: 10.1371/journal.pone.0314853. eCollection 2025. |
| 38957572 | Background | Nakornnoi T, Bunjerdjin P, Santiwong P, Sipiyaruk K, Neoh SP, Chintavalakorn R. The Influence of Thickness on the Mechanical Behaviors of 3D Printing Resins for Orthodontic Retainers. Int J Biomater. 2024 Jun 25;2024:7398478. doi: 10.1155/2024/7398478. eCollection 2024. |
| 34797378 | Background | Ashari A, Xian L, Syed Mohamed AMF, Wahab RMA, Kit YC, Tata MD, Sinnasamy S, Kuppusamy E. One-year comparative assessment of retention of arch width increases between modified vacuum-formed and Hawley retainers. Angle Orthod. 2022 Mar 1;92(2):197-203. doi: 10.2319/050921-363.1. |
| 36018418 | Background | Ashari A, Nik Mustapha NM, Yuen JJX, Saw ZK, Lau MN, Xian L, Syed Mohamed AMF, Megat Abdul Wahab R, Yeoh CK, Deva Tata M, Sinnasamy S. A two-year comparative assessment of retention of arch width increases between modified vacuum-formed and Hawley retainers: a multi-center randomized clinical trial. Prog Orthod. 2022 Aug 26;23(1):40. doi: 10.1186/s40510-022-00424-5. |
| 38351789 | Background | Stoev YY, Uzunov TT, Stoyanova NS, Grozdanova-Uzunova RG, Kosturkov DN, Taneva IK. Mechanical properties of materials for 3D printed orthodontic retainers. Folia Med (Plovdiv). 2023 Dec 31;65(6):986-992. doi: 10.3897/folmed.65.e107299. |
| 39709226 | Background | Neoh SP, Khantachawana A, Chintavalakorn R, Santiwong P, Srikhirin T. Comparison of physical, mechanical, and optical properties between thermoplastic materials and 3-dimensional printing resins for orthodontic clear retainers. Am J Orthod Dentofacial Orthop. 2025 Jan;167(1):95-109.e1. doi: 10.1016/j.ajodo.2024.06.010. |
| Jun 15, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 15, 2026 | Jun 15, 2026 | ICF_001.pdf |