Orthodontic RetentionNCT05968625
3D-Printed Vs Thermoformed Retainers: Comparison of Post-Treatment Stability, Changes in Mechanical Properties and Patients' OHRQoL
A study testing Thermoformed retainers and 3D-printed retainers in people with Orthodontic Retention, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Retention
- What is being tested?
- Thermoformed retainers and 3D-printed retainers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 28 Mar 2023to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Orthodontic Postgraduate Clinic, Faculty of Dentistry, Universiti Malaya.
Kuala Lumpur, Kuala Lumpur, 50603
Dr. Boo Hui Shan, +60102705306, 17080312@siswa.um.edu.my
Associate Professor Dr. Saritha Sivarajan, +60379674802 ext. 4562, saritha@um.edu.my
About this study
Official title: Post-Treatment Stability, Changes in Mechanical Properties and Patients' OHRQoL Of Direct 3D-Printed Retainers Versus Thermoformed Retainers: An Open-label Randomized Controlled Trial
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.
Read the detailed description
Primary Objective:
- 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:
- To determine and compare the thickness and mechanical properties for 3DPR and TFR after 6 months of usage.
- 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
- Orthodontic Retention
- Being tested
- Thermoformed retainers, 3D-printed retainers
- Keywords
- Thermoformed retainers, 3D-printed retainers, vacuum-formed retainers, Post-treatment stability, Orthodontics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermoformed retainersDevice
conventional thermoformed retainers fabricated on stone models.
3D-printed retainersDevice
3D-printed retainers fabricated directly by DLP printer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: 3D-printed retainers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Changes in thickness of retainers
Measurements of changes in thickness (mm) will be performed by the principal investigator by using an electronic digital thickness gauge with a resolution of 0.01 mm and accuracy of ±0.02 mm, which will be calibrated before each use.
Measured: 6 months
Changes in hardness of retainers
The extra sets of retainers (5 sets from each group) at T0 and the retrieved retainers (5 sets from each group) at T2 of each group will be tested. The hardness that will be determined is Vickers hardness in Megapascal (MPa). A universal hardness testing machine (DUH-211S, Shimadzu, Kyoto Japan) will be used to determine the hardness.
Measured: 6 months
Oral Health Impact Profile -14 (OHIP-14)
This research will use the validated Modified short version of the OHIP-14 for Malaysian adults with questions that are relevant to subjects wearing removable retainers. Responses to each item will be scored on a five-point Likert scale measuring from never (score 0) to very often (score 4). The OHIP-14 questionnaire will be given to the participants to answer during T0, T1 and T2.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start28 Mar 2023
- Primary completionMay 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Orthodontic RetentionStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Direct 3D-printed retainers
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR BOO HUI SHAN, University of Malaya
- Investigators
- Associate Professor Dr. Saritha Sivarajan, Study director, Faculty of Dentistry, Universiti Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968625
- Sponsor's protocol ID
- UNIVERSITI MALAYA
- Other IDs
- UMG013E-2023
- Status last verified
- Sep 2023
- First submitted
- 17 Jul 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35012743Rowland 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.
PubMed 18068589Naeem 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.
PubMed 35337648Kumar AG, Bansal A. Effectiveness and acceptability of Essix and Begg retainers: a prospective study. Aust Orthod J. 2011 May;27(1):52-6.
PubMed 21696115Kessler 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.
PubMed 31172871Jindal 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.
PubMed 31677678Etemad-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.
PubMed 33092047Cousley RR. Introducing 3D printing in your orthodontic practice. J Orthod. 2020 Sep;47(3):265-272. doi: 10.1177/1465312520936704. Epub 2020 Jul 6.
PubMed 32627658Cole 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.
PubMed 30935614Can 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.
PubMed 33950232Al-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.
PubMed 28651764Al-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.
PubMed 34117437Thickett 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.
PubMed 19828592Saub 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.
PubMed 16128798Mohd 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.
PubMed 30321319
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Treatment Stability, Changes in Mechanical Properties and Patients' OHRQoL Of Direct 3D-Printed Retainers Versus Thermoformed Retainers: An Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05968625
- Acronym / sponsor ID
- UNIVERSITI MALAYA
- Conditions
- Orthodontic Retention
- Keywords
- Thermoformed retainers, 3D-printed retainers, vacuum-formed retainers, Post-treatment stability, Orthodontics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective:
- 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:
- To determine and compare the thickness and mechanical properties for 3DPR and TFR after 6 months of usage.
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Direct 3D-printed retainers
| Arm | Type | Receives |
|---|---|---|
| Thermoformed retainers (TFR) | Experimental | Device: Thermoformed retainersThermoformed retainers are constructed from an Erkodur blank (ERKODENT® Erich Kopp GmbH, Pfalzgrafenweiler, Germany) with 1.0 mm in thickness, following the manufacturer's instructions. |
| Direct 3-D printed retainers (3DPR) | Experimental | Device: 3D-printed retainersPrivate dental laboratories directly print the retainers using a NextDent 3D printer and NextDent ortho Flex resin. Thickness of 0.80mm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermoformed retainersconventional thermoformed retainers fabricated on stone models. | Device | Thermoformed retainers (TFR) |
| 3D-printed retainers3D-printed retainers fabricated directly by DLP printer. | Device | Direct 3-D printed retainers (3DPR) |
Primary outcome
Post-treatment stability
Time frame: 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 (3Shape A/S, Copenhagen, Denmark). Measurements: Overjet (mm), Overbite (mm), Intermolar width (mm), and little irregularity index (mm). All the measurements are in millimetres.
3 secondary outcomes
Changes in thickness of retainers
Time frame: 6 months
Changes in hardness of retainers
Time frame: 6 months
Oral Health Impact Profile -14 (OHIP-14)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Background: PubMed 35012743Williams 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.
- Background: PubMed 18068589Rowland 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.
- Background: PubMed 35337648Naeem 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.
- Background: PubMed 21696115Kumar AG, Bansal A. Effectiveness and acceptability of Essix and Begg retainers: a prospective study. Aust Orthod J. 2011 May;27(1):52-6.
- Background: PubMed 31172871Kessler 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.
- Background: PubMed 31677678Jindal 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.
- Background: PubMed 33092047Etemad-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.
- Background: PubMed 32627658Cousley RR. Introducing 3D printing in your orthodontic practice. J Orthod. 2020 Sep;47(3):265-272. doi: 10.1177/1465312520936704. Epub 2020 Jul 6.
- Background: PubMed 30935614Cole 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.
- Background: PubMed 33950232Can 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.
- Background: PubMed 28651764Al-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.
- Background: PubMed 34117437Al-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Associate Professor Dr. Saritha Sivarajan study director
Faculty of Dentistry, Universiti Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermoformed retainers and 3D-printed retainers in people with Orthodontic Retention, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Boo Hui Shan (+60102705306, 17080312@siswa.um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-treatment stability (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05968625, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.