3D-Printed Vs Thermoformed Retainers: Comparison of Post-Treatment Stability, Changes in Mechanical Properties and Patients' OHRQoL

NCT05968625 | Unknown

• 2 other identifiers: UNIVERSITI MALAYAUMG013E-2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Following completion of orthodontic treatment, prolonged retention with either part-time or full-time wear of retainers is crucial in preventing relapse. Clear thermoformed retainers (TFR) are easy to fabricate and popular among orthodontic patients. With the advent of digital orthodontics and the development of biocompatible photopolymerizable resin, it is now possible to fabricate direct 3D-printed retainers. 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.

Conditions

Orthodontic Retention

Keywords

Thermoformed retainers; 3D-printed retainers; vacuum-formed retainers; Post-treatment stability; Orthodontics

Outcome Measures

Primary Outcomes (1)

• Post-treatment stability

  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 (3Shape A/S, Copenhagen, Denmark). Measurements: Overjet (mm), Overbite (mm), Intermolar width (mm), and little irregularity index (mm). All the measurements are in millimetres.

  6 months

Secondary Outcomes (3)

• Changes in thickness of retainers

  6 months

• Changes in hardness of retainers

  6 months

• Oral Health Impact Profile -14 (OHIP-14)

  6 months

Study Arms (2)

Thermoformed retainers (TFR)

EXPERIMENTAL

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.

Device: Thermoformed retainers

Direct 3-D printed retainers (3DPR)

EXPERIMENTAL

Private dental laboratories directly print the retainers using a NextDent 3D printer and NextDent ortho Flex resin. Thickness of 0.80mm

Device: 3D-printed retainers

Interventions

Thermoformed retainers DEVICE

conventional thermoformed retainers fabricated on stone models.

Thermoformed retainers (TFR)

3D-printed retainers DEVICE

3D-printed retainers fabricated directly by DLP printer.

Direct 3-D printed retainers (3DPR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fixed appliance treatment in both arches and indicated for VFR in the retention phase as part of their original treatment plan.
• No intention to relocate within the study period; able to attend the three-monthly review appointments for half a year.

You may not qualify if:

• Single-arch or sectional fixed appliances.
• 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

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 (15)

• 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.

  PMID: 35012743 BACKGROUND

• 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.

  PMID: 18068589 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.

  PMID: 35337648 BACKGROUND

• Kumar AG, Bansal A. Effectiveness and acceptability of Essix and Begg retainers: a prospective study. Aust Orthod J. 2011 May;27(1):52-6.

  PMID: 21696115 BACKGROUND

• 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.

  PMID: 31172871 BACKGROUND

• 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.

  PMID: 31677678 BACKGROUND

• 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.

  PMID: 33092047 BACKGROUND

• 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.

  PMID: 32627658 BACKGROUND

• 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.

  PMID: 30935614 BACKGROUND

• 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.

  PMID: 33950232 BACKGROUND

• 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.

  PMID: 28651764 BACKGROUND

• 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.

  PMID: 34117437 BACKGROUND

• 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.

  PMID: 19828592 BACKGROUND

• 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.

  PMID: 16128798 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

Study Officials

• Associate Professor Dr. Saritha Sivarajan

  Faculty of Dentistry, Universiti Malaya

  STUDY DIRECTOR

Central Study Contacts

Dr. Boo Hui Shan

CONTACT

+60102705306; 17080312@siswa.um.edu.my

Associate Professor Dr. Saritha Sivarajan

CONTACT

+6037967 4802; saritha@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-blinded study, where the statistician that analyzes the data is blinded. The subjects are impossible to blind due to subtle differences in the physical appearance of both appliances. Blinding of the operator will not be possible due to the differences in clinical procedures involved in fabrication of TFR and 3DPR.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Doctorate (Orthodontics) Postgraduate Student

Model Details: Direct 3D-printed retainers

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 1, 2023
• Study Start: March 28, 2023
• Primary Completion: May 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)