3D-Printed Vs Thermoformed Retainers: Comparison of Post-Treatment Stability, Changes in Mechanical Properties and Patients' OHRQoL
NCT ID: NCT05968625
Last Updated: 2023-09-08
Study Results
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Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2023-03-28
2024-10-31
Brief Summary
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The aim of this study is to determine and compare the post-treatment stability of dentition, changes in thickness and mechanical properties of the retainers, and oral health-related quality of life (OHRQoL) of patients wearing direct 3D-printed retainers and conventional thermoformed retainers over a retention period of 6 months.
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Detailed Description
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1\. To determine and compare the post-treatment stability for direct 3D printed retainers (3DPR) and conventional TFR (TFR) at baseline (T0), 3 months (T1) and 6 months (T2).
Secondary Objectives:
1. To determine and compare the thickness and mechanical properties for 3DPR and TFR after 6 months of usage.
2. To determine and compare the OHRQoL of patients wearing 3DPR and TFR at T0, T1 and T2.
Sample size calculation:
Sample size calculation is based on the study done by Kumar \& Bansal (2011) which compared the effectiveness of two different removable retainers on stability. With an effect size of 1.127, α = 0.05, and power = 0.80. Using G\*Power version 3.1.9.7 software, the total number of samples is n = 22 (11 subject per group). This number is increased by 30% to account for the dropout rate to produce the final sample size, n = 30 (15 subjects per group).
Methodology:
Subjects who have completed their orthodontic treatment (fulfil the inclusion and exclusion criteria) and are ready for debond, will be invited to participate in the research and consecutively recruited, between April 2023 until September 2023, in the Postgraduate Orthodontic Clinic, Dental Specialists and Research Tower, Faculty of Dentistry, Universiti Malaya, Malaysia. Patient information sheets and consent forms will be issued to the subjects that fulfil the criteria. Only consented respondents will be recruited.
All 30 subjects will be randomly allocated (simple randomization with 1:1 allocation) to either the TFR group or the 3DPR group by using number generated list provided by www.random.org . The randomization will be performed by the main supervisor, who is not involve in the treatment, data collection and data analysis of the research. The operator will be concealed from the group allocation. The allocation will be revealed to the operator on the day of debond appointment with a opaque white envelope.
All the subjects will undergo the same standard debond process. and receive a post debond thermoformed retainers within 24 hours which they are required to part-time for every night (8-12 hours).
The subjects will be reviewed after 1 week (T0) for scanning of teeth with Trios 3 intraoral scanner. The interventional retainers (TFR or 3DPR) will be issued after 2 weeks. The subjects are instructed to wear the retainers part-time (8-12 hours) for every nights. A pamphlet that contains detailed information on the care of retainers will also be provided to every subject. All the subjects will be reviewed after 3 months (T1) and at 6 months (T2) after wearing the interventional retainers.
The primary outcome is to assess the post-treatment stability after part time wear of the retainers for a period of 6 months. The subject's upper and lower dentition will be scanned by using intraoral scanner at T0, T1, and T2. The measurements will be performed digitally using 3Shape orthodontic analyzer software. Overjet, overbite, intermolar width, and little irregularity index will be measured.
OHIP-14 questionnaire will be given to the participants to answer during T0, T1 and T2. All the retainers will be retrieved at T2 to undergo mechanical test.
Statistical Analysis:
The data collected will be entered into SPSS software (version 26.0). i. Chi-square tests will be used to compare baseline characteristics between the 2 groups.
ii. Repeated measures ANOVA or paired t-test will be used to determine the mean differences in post treatment stability, thickness of retainers, mechanical properties of retainers and OHIP-14 scores at different time intervals. The p-value will be set to less than 0.05.
iii. Two samples independent t test will be used to compare the post-treatment stability, changes in thickness, mechanical properties, and OHIP-14 scores between TFR and 3DPR group. The p-value will be set to less than 0.05.
iv. Shapiro-Wilk tests will be referred, and non-parametric tests will be performed for skewed data.
Data will be analyzed following the intention-to-treat analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Blinding of the operator will not be possible due to the differences in clinical procedures involved in fabrication of TFR and 3DPR.
Study Groups
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Thermoformed retainers (TFR)
Thermoformed retainers are constructed from an Erkodur blank (ERKODENT® Erich Kopp GmbH, Pfalzgrafenweiler, Germany) with 1.0 mm in thickness, following the manufacturer's instructions.
Thermoformed retainers
conventional thermoformed retainers fabricated on stone models.
Direct 3-D printed retainers (3DPR)
Private dental laboratories directly print the retainers using a NextDent 3D printer and NextDent ortho Flex resin. Thickness of 0.80mm
3D-printed retainers
3D-printed retainers fabricated directly by DLP printer.
Interventions
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Thermoformed retainers
conventional thermoformed retainers fabricated on stone models.
3D-printed retainers
3D-printed retainers fabricated directly by DLP printer.
Eligibility Criteria
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Inclusion Criteria
* No intention to relocate within the study period; able to attend the three-monthly review appointments for half a year.
Exclusion Criteria
* Space dentition.
* Hypodontia requiring tooth replacement on the retainer as a temporary measure.
* Previous treatment with maxillary expansion.
* Indicated for fixed retainer or double retention regime (such as VFRs fitted over fixed retainers).
* Premature debond from the original fixed appliances course.
* Cleft lip and/or palate; or orthognathic cases.
* Learning difficulties and inability to read written instructions/ questionnaire in English or Malay
18 Years
ALL
Yes
Sponsors
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University of Malaya
OTHER
Responsible Party
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DR BOO HUI SHAN
Principle Investigator, Doctorate (Orthodontics) Postgraduate Student
Principal Investigators
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Associate Professor Dr. Saritha Sivarajan
Role: STUDY_DIRECTOR
Faculty of Dentistry, Universiti Malaya
Locations
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Orthodontic Postgraduate Clinic, Faculty of Dentistry, Universiti Malaya.
Kuala Lumpur, Kuala Lumpur, Malaysia
Countries
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Central Contacts
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Facility Contacts
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References
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Williams A, Bencharit S, Yang IH, Stilianoudakis SC, Carrico CK, Tufekci E. Effect of print angulation on the accuracy and precision of 3D-printed orthodontic retainers. Am J Orthod Dentofacial Orthop. 2022 Jan;161(1):133-139. doi: 10.1016/j.ajodo.2021.01.020.
Rowland H, Hichens L, Williams A, Hills D, Killingback N, Ewings P, Clark S, Ireland AJ, Sandy JR. The effectiveness of Hawley and vacuum-formed retainers: a single-center randomized controlled trial. Am J Orthod Dentofacial Orthop. 2007 Dec;132(6):730-7. doi: 10.1016/j.ajodo.2006.06.019.
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.
Kumar AG, Bansal A. Effectiveness and acceptability of Essix and Begg retainers: a prospective study. Aust Orthod J. 2011 May;27(1):52-6.
Kessler A, Hickel R, Reymus M. 3D Printing in Dentistry-State of the Art. Oper Dent. 2020 Jan/Feb;45(1):30-40. doi: 10.2341/18-229-L. Epub 2019 Jun 7.
Jindal P, Juneja M, Siena FL, Bajaj D, Breedon P. Mechanical and geometric properties of thermoformed and 3D printed clear dental aligners. Am J Orthod Dentofacial Orthop. 2019 Nov;156(5):694-701. doi: 10.1016/j.ajodo.2019.05.012.
Etemad-Shahidi Y, Qallandar OB, Evenden J, Alifui-Segbaya F, Ahmed KE. Accuracy of 3-Dimensionally Printed Full-Arch Dental Models: A Systematic Review. J Clin Med. 2020 Oct 20;9(10):3357. doi: 10.3390/jcm9103357.
Cousley RR. Introducing 3D printing in your orthodontic practice. J Orthod. 2020 Sep;47(3):265-272. doi: 10.1177/1465312520936704. Epub 2020 Jul 6.
Cole D, Bencharit S, Carrico CK, Arias A, Tufekci E. Evaluation of fit for 3D-printed retainers compared with thermoform retainers. Am J Orthod Dentofacial Orthop. 2019 Apr;155(4):592-599. doi: 10.1016/j.ajodo.2018.09.011.
Can E, Panayi N, Polychronis G, Papageorgiou SN, Zinelis S, Eliades G, Eliades T. In-house 3D-printed aligners: effect of in vivo ageing on mechanical properties. Eur J Orthod. 2022 Jan 25;44(1):51-55. doi: 10.1093/ejo/cjab022.
Al-Moghrabi D, Salazar FC, Pandis N, Fleming PS. Compliance with removable orthodontic appliances and adjuncts: A systematic review and meta-analysis. Am J Orthod Dentofacial Orthop. 2017 Jul;152(1):17-32. doi: 10.1016/j.ajodo.2017.03.019.
Al-Moghrabi D, Littlewood SJ, Fleming PS. Orthodontic retention protocols: an evidence-based overview. Br Dent J. 2021 Jun;230(11):770-776. doi: 10.1038/s41415-021-2954-7. Epub 2021 Jun 11.
Thickett E, Power S. A randomized clinical trial of thermoplastic retainer wear. Eur J Orthod. 2010 Feb;32(1):1-5. doi: 10.1093/ejo/cjp061. Epub 2009 Oct 14.
Saub R, Locker D, Allison P. Derivation and validation of the short version of the Malaysian Oral Health Impact Profile. Community Dent Oral Epidemiol. 2005 Oct;33(5):378-83. doi: 10.1111/j.1600-0528.2005.00242.x.
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.
Other Identifiers
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UMG013E-2023
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UNIVERSITI MALAYA
Identifier Type: -
Identifier Source: org_study_id
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