Orthodontic Appliance ComplicationNCT03844425
Microbial Colonisation On Vacuum-Formed Retainers Constructed On Conventional Models And Three Dimensional (3D) Reconstructed Models
A study testing Conventional VFR, VFR from SLA and VFR from FDM in people with Orthodontic Appliance Complication, run by University of Malaya at 1 site in Malaysia.
Trial summary
Vacuum-formed retainers are clear or transparent retainers, that hold the teeth in the new position after active orthodontic treatment. These custom made appliances are becoming popular these days due to the aesthetics value among patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Conventional VFR, VFR from SLA and VFR from FDM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteMalaysia
- Study dates
- 2 Dec 2019to 10 Apr 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Fixed appliance on upper and lower arches ii. About to debond iii. Planned for vacuum-formed retainers for retention iv. Non smoking patients v. No systemic disease
Who cannot join
- Undergoing sectional fixed appliance / single arch treatment ii. Indicated for double retention regime with bonded retainers iii. Patient with smoking habit iv. Any systemic disease that may affect the salivary flow v. History of use of antimicrobial mouthwash less than 1 month prior to debond
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Postgraduate Orthodontic Clinic, Faculty Of Dentistry, University Of Malaya
Kuala Lumpur, 50603
About this study
Official title: Microbial Colonisation On Vacuum-Formed Retainers With Different Surface Roughness As Constructed On Conventional Models And Three Dimensional (3D) Reconstructed Models
Vacuum-formed retainers are clear or transparent retainers, that hold the teeth in the new position after active orthodontic treatment. These custom made appliances are becoming popular these days due to the aesthetics value among patients.
Vacuum-formed retainers can be made through a process that softens the clear plastic and vacuumed to follow the shape of the dental model before it cools off and hardens again. These dental models can be made from conventional method or through a 3D reconstruction process. Recently, it was found that there is no difference in terms of stability of the teeth and oral health related quality of life of the patients wearing vacuum-formed retainers constructed on either types of models.
Read more
Physically, the surface roughness of the retainers appear different because the conventional models and 3D printed models are constructed in a different manner.
Our interest is to determine whether the difference in surface roughness would affect microbial colonisation which can eventually affect the oral health.
So this study aims to find the association between microbial colonisation and surface roughness of vacuum-formed retainers constructed on conventional models and also 3D reconstructed models.
Read the detailed description
RATIONALE OF STUDY
The vacuum-formed retainers are widely preferred today but there is limited research on the effects of the retainers on microbial colonisation, which can have an impact on the oral health. There is possibility that a rough surface finishing of the vacuum-formed retainers may lead to increased microbial colonisation. Therefore, there is a need for us to investigate if the vacuum formed retainers made on 3D reconstructed models may produce increased surface roughness which then can lead to increased microbial colonisation and later impacts the oral health.
Primary Objective :
- To determine the association between different surface roughness of vacuum- formed retainers and microbial colonisation.
Secondary Objectives :
- To compare the surface roughness of vacuum-formed retainers constructed on conventional models and 3D reconstructed models.
- To compare the microbial colonisation on vacuum-formed retainers with different roughness as constructed on conventional models and 3D reconstructed models.
- To compare the microbial colonisation between upper and lower vacuum-formed retainers with different surface roughness.
- To compare the microbial colonisation on vacuum-formed retainers with different surface roughness between full time wear and part time wear.
SAMPLE SIZE CALCULATION
Sample size calculation is done based on a type 1 error frequency of 5% and the power of the statistical test is set at 80%. This is based on a study done by Farhadian et al, 2016 on Streptococcus colonisation on orthodontic retainers. The total number of participant needed for the trial was 27 with a minimum of 9 participants per group. With an anticipated 20% drop outs, a total number of 36 patients will be recruited.
Methodology
Patients who are currently undergoing fixed appliance treatment at Faculty of Dentistry, University of Malaya will be screened for their progress of treatment and whether they are ready for debond. During screening, patients who fit the inclusion and exclusion criteria will be selected and given a patient information sheet and a detailed explanation of the clinical trial. Voluntarily participant will then be recruited into this study and informed consent will be obtained. A total number of 36 participants will be recruited for this clinical trial.
Participants will be drawing lots to obtain their study number. Then, the orthodontic resident will have to check the group allocation with the orthodontic consultant.
During the first appointment, debond procedure will be done according to the standard protocol. Three sets of impression will be taken for the construction of study model, construction of the standard retainers and also for the research purpose. The standard retainers will then be issued on the same day of debond (T0). Participants will be instructed to wear the retainers full time except during brushing, cleaning of the appliance and during meals.
Participants will be reviewed one week post debond (T1). During this appointment, the standard retainers will be taken and kept by the orthodontic resident. The first interventional retainers will be issued and participants are advised to wear the retainers full time / 24 hours except during meals, brushing and cleaning of the appliance. Participants will be given a new retainer box to keep their retainers as well as a new toothbrush for cleaning their appliance. A pamphlet that contains detailed information on the care of retainers will also be provided to every participant. Participants will be reminded regularly to wear their retainers full time / 24 hours for three months.
Participants will be reviewed again 3 months post debond (T2). During this appointment, the first interventional retainers will be taken and kept by the orthodontic resident. Then the second interventional retainers will be issued and participants are advised to wear the retainers for 10 hours only. Participants will also be given a new retainer box to keep their retainers as well as a new toothbrush for cleaning their appliance. Analysis of the first interventional retainers will then be carried out. Participants will also be reminded regularly to wear their retainers for 10 hours only for 3 months.
Participants will be reviewed again 6 months post debond (T3). During this appointment, the second interventional retainers will be taken and kept by the orthodontic resident. Then the standard retainers will be issued back and participants are advised to continue wearing the retainers for 10 hours only. Analysis of the second interventional retainers will then be carried out.
STATISTICAL ANALYSIS
Statistical Analysis will be done using SPSS software version 21. P < 0.05 will be set as the level of significance.
- One way analysis of variance (ANOVA) will be used to compare the surface roughness and microbial colonization on vacuum-formed retainers constructed on conventional models and 3D reconstructed models. ii. Paired Sample T-Test will be used to compare the microbial colonization between the upper and lower vacuum-formed retainers with different surface roughness as well as between full time wear and part time wear. iii. Correlation will be used to determine the association between surface roughness of vacuum-formed retainers and microbial colonization.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Conventional VFR, VFR from SLA, VFR from FDM
- Keywords
- Orthodontic Retainers, Printing, Three-Dimensional, Colony Count, Microbial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional VFRDevice
Conventional retainers
VFR from SLADevice
SLA has better finishing compared to FDM but it is more expensive.
VFR from FDMDevice
FDM has poorer finishing compared to SLA but it is cheaper.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Vacuum-Formed Retainers | Active comparator | Vacuum-formed retainers constructed on conventional stone models. Receives: Device: Conventional VFR |
| Vacuum-Formed Retainers From SLA | Experimental | Vacuum-formed retainers constructed on 3D reconstructed models using stereolitography (SLA) technique. Receives: Device: VFR from SLA |
| Vacuum-Formed Retainers From FDM | Experimental | Vacuum-formed retainers constructed on 3D reconstructed models using fused deposition modeling technique (FDM). Receives: Device: VFR from FDM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial Colonisation On Vacuum-Formed Retainers
Microbial colony count on the vacuum-formed retainers constructed on conventional models \& 3D reconstructed models.
The vacuum-formed retainers that are collected from the patients will be placed in BHI media and then 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.
Measured: 6 months
Secondary outcomes (1)
Surface Roughness Of Vacuum-Formed Retainers
Surface roughness values of vacuum-formed retainers constructed on conventional models \& 3D reconstructed models.
The surface roughness of the vacuum-formed retainers will be measured using Alicona 3D Surface Management System. Vacuum-formed retainers which are new and used by patient (after disinfection) will be placed for surface roughness assessment under the microscope and the value which is measured as Ra (profile roughness parameter) will be recorded.
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 posted18 Feb 2019
- Study start2 Dec 2019
- Primary completion10 Apr 2021
- Study completion10 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Wan Nurazreena Wan Hassan, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844425
- Sponsor's protocol ID
- DGD_170002
- Status last verified
- May 2021
- First submitted
- 14 Feb 2019
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dawes C, Watanabe S, Biglow-Lecomte P, Dibdin GH. Estimation of the velocity of the salivary film at some different locations in the mouth. J Dent Res. 1989 Nov;68(11):1479-82. doi: 10.1177/00220345890680110201.
PubMed 2531176Dawes C. Salivary flow patterns and the health of hard and soft oral tissues. J Am Dent Assoc. 2008 May;139 Suppl:18S-24S. doi: 10.14219/jada.archive.2008.0351.
PubMed 18460676Dietrich CA, Ender A, Baumgartner S, Mehl A. A validation study of reconstructed rapid prototyping models produced by two technologies. Angle Orthod. 2017 Sep;87(5):782-787. doi: 10.2319/01091-727.1. Epub 2017 May 1.
PubMed 28459285Hazeveld A, Huddleston Slater JJ, Ren Y. Accuracy and reproducibility of dental replica models reconstructed by different rapid prototyping techniques. Am J Orthod Dentofacial Orthop. 2014 Jan;145(1):108-15. doi: 10.1016/j.ajodo.2013.05.011.
PubMed 24373661Hibino K, Wong RW, Hagg U, Samaranayake LP. The effects of orthodontic appliances on Candida in the human mouth. Int J Paediatr Dent. 2009 Sep;19(5):301-8. doi: 10.1111/j.1365-263X.2009.00988.x. Epub 2009 Apr 16.
PubMed 19486368Hichens 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.
PubMed 17702797Kasparova M, Grafova L, Dvorak P, Dostalova T, Prochazka A, Eliasova H, Prusa J, Kakawand S. Possibility of reconstruction of dental plaster cast from 3D digital study models. Biomed Eng Online. 2013 May 31;12:49. doi: 10.1186/1475-925X-12-49.
PubMed 23721330Keating AP, Knox J, Bibb R, Zhurov AI. A comparison of plaster, digital and reconstructed study model accuracy. J Orthod. 2008 Sep;35(3):191-201; discussion 175. doi: 10.1179/146531207225022626.
PubMed 18809782Kim GB, Lee S, Kim H, Yang DH, Kim YH, Kyung YS, Kim CS, Choi SH, Kim BJ, Ha H, Kwon SU, Kim N. Three-Dimensional Printing: Basic Principles and Applications in Medicine and Radiology. Korean J Radiol. 2016 Mar-Apr;17(2):182-97. doi: 10.3348/kjr.2016.17.2.182. Epub 2016 Mar 2.
PubMed 26957903Low B, Lee W, Seneviratne CJ, Samaranayake LP, Hagg U. Ultrastructure and morphology of biofilms on thermoplastic orthodontic appliances in 'fast' and 'slow' plaque formers. Eur J Orthod. 2011 Oct;33(5):577-83. doi: 10.1093/ejo/cjq126. Epub 2010 Dec 27.
PubMed 21187528Mamai-Homata E, Koletsi-Kounari H, Margaritis V. Gender differences in oral health status and behavior of Greek dental students: A meta-analysis of 1981, 2000, and 2010 data. J Int Soc Prev Community Dent. 2016 Jan-Feb;6(1):60-8. doi: 10.4103/2231-0762.175411.
PubMed 27011935Marsh PD. The role of microbiology in models of dental caries. Adv Dent Res. 1995 Nov;9(3):244-54; discussion 255-69. doi: 10.1177/08959374950090030901.
PubMed 8615947Quirynen M, Marechal M, Busscher HJ, Weerkamp AH, Darius PL, van Steenberghe D. The influence of surface free energy and surface roughness on early plaque formation. An in vivo study in man. J Clin Periodontol. 1990 Mar;17(3):138-44. doi: 10.1111/j.1600-051x.1990.tb01077.x.
PubMed 2319000Thickett 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 19828592Turkoz C, Canigur Bavbek N, Kale Varlik S, Akca G. Influence of thermoplastic retainers on Streptococcus mutans and Lactobacillus adhesion. Am J Orthod Dentofacial Orthop. 2012 May;141(5):598-603. doi: 10.1016/j.ajodo.2011.11.021.
PubMed 22554754
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial Colonisation On Vacuum-Formed Retainers With Different Surface Roughness As Constructed On Conventional Models And Three Dimensional (3D) Reconstructed Models
- ClinicalTrials.gov ID
- NCT03844425
- Acronym / sponsor ID
- DGD_170002
- Conditions
- Orthodontic Appliance Complication
- Keywords
- Orthodontic Retainers, Printing, Three-Dimensional, Colony Count, Microbial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 18 Feb 2019 (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.
Vacuum-formed retainers are clear or transparent retainers, that hold the teeth in the new position after active orthodontic treatment. These custom made appliances are becoming popular these days due to the aesthetics value among patients.
Vacuum-formed retainers can be made through a process that softens the clear plastic and vacuumed to follow the shape of the dental model before it cools off and hardens again. These dental models can be made from conventional method or through a 3D reconstruction process. Recently, it was found that there is no difference in terms of stability of the teeth and oral health related quality of life of the patients wearing vacuum-formed retainers constructed on either types of models.
Physically, the surface roughness of the retainers appear different because the conventional models and 3D printed models are constructed in a different manner.
Our interest is to determine whether the difference in surface roughness would affect microbial colonisation which can eventually affect the oral health.
So this study aims to find the association between microbial colonisation and surface roughness of vacuum-formed retainers constructed on conventional models and also 3D reconstructed models.
Detailed description
RATIONALE OF STUDY
The vacuum-formed retainers are widely preferred today but there is limited research on the effects of the retainers on microbial colonisation, which can have an impact on the oral health. There is possibility that a rough surface finishing of the vacuum-formed retainers may lead to increased microbial colonisation. Therefore, there is a need for us to investigate if the vacuum formed retainers made on 3D reconstructed models may produce increased surface roughness which then can lead to increased microbial colonisation and later impacts the oral health.
Primary Objective :
- To determine the association between different surface roughness of vacuum- formed retainers and microbial colonisation.
Secondary Objectives :
- To compare the surface roughness of vacuum-formed retainers constructed on conventional models and 3D reconstructed models.
- To compare the microbial colonisation on vacuum-formed retainers with different roughness as constructed on conventional models and 3D reconstructed models.
- To compare the microbial colonisation between upper and lower vacuum-formed retainers with different surface roughness.
- To compare the microbial colonisation on vacuum-formed retainers with different surface roughness between full time wear and part time wear.
SAMPLE SIZE CALCULATION
Sample size calculation is done based on a type 1 error frequency of 5% and the power of the statistical test is set at 80%. This is based on a study done by Farhadian et al, 2016 on Streptococcus colonisation on orthodontic retainers. The total number of participant needed for the trial was 27 with a minimum of 9 participants per group. With an anticipated 20% drop outs, a total number of 36 patients will be recruited.
Methodology
Patients who are currently undergoing fixed appliance treatment at Faculty of Dentistry, University of Malaya will be screened for their progress of treatment and whether they are ready for debond. During screening, patients who fit the inclusion and exclusion criteria will be selected and given a patient information sheet and a detailed explanation of the clinical trial. Voluntarily participant will then be recruited into this study and informed consent will be obtained. A total number of 36 participants will be recruited for this clinical trial.
Participants will be drawing lots to obtain their study number. Then, the orthodontic resident will have to check the group allocation with the orthodontic consultant.
During the first appointment, debond procedure will be done according to the standard protocol. Three sets of impression will be taken for the construction of study model, construction of the standard retainers and also for the research purpose. The standard retainers will then be issued on the same day of debond (T0). Participants will be instructed to wear the retainers full time except during brushing, cleaning of the appliance and during meals.
Participants will be reviewed one week post debond (T1). During this appointment, the standard retainers will be taken and kept by the orthodontic resident. The first interventional retainers will be issued and participants are advised to wear the retainers full time / 24 hours except during meals, brushing and cleaning of the appliance. Participants will be given a new retainer box to keep their retainers as well as a new toothbrush for cleaning their appliance. A pamphlet that contains detailed information on the care of retainers will also be provided to every participant. Participants will be reminded regularly to wear their retainers full time / 24 hours for three months.
Participants will be reviewed again 3 months post debond (T2). During this appointment, the first interventional retainers will be taken and kept by the orthodontic resident. Then the second interventional retainers will be issued and participants are advised to wear the retainers for 10 hours only. Participants will also be given a new retainer box to keep their retainers as well as a new toothbrush for cleaning their appliance. Analysis of the first interventional retainers will then be carried out. Participants will also be reminded regularly to wear their retainers for 10 hours only for 3 months.
Participants will be reviewed again 6 months post debond (T3). During this appointment, the second interventional retainers will be taken and kept by the orthodontic resident. Then the standard retainers will be issued back and participants are advised to continue wearing the retainers for 10 hours only. Analysis of the second interventional retainers will then be carried out.
STATISTICAL ANALYSIS
Statistical Analysis will be done using SPSS software version 21. P < 0.05 will be set as the level of significance.
- One way analysis of variance (ANOVA) will be used to compare the surface roughness and microbial colonization on vacuum-formed retainers constructed on conventional models and 3D reconstructed models. ii. Paired Sample T-Test will be used to compare the microbial colonization between the upper and lower vacuum-formed retainers with different surface roughness as well as between full time wear and part time wear. iii. Correlation will be used to determine the association between surface roughness of vacuum-formed retainers and microbial colonization.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Vacuum-Formed Retainers | Active comparator | Device: Conventional VFRVacuum-formed retainers constructed on conventional stone models. |
| Vacuum-Formed Retainers From SLA | Experimental | Device: VFR from SLAVacuum-formed retainers constructed on 3D reconstructed models using stereolitography (SLA) technique. |
| Vacuum-Formed Retainers From FDM | Experimental | Device: VFR from FDMVacuum-formed retainers constructed on 3D reconstructed models using fused deposition modeling technique (FDM). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Fixed appliance on upper and lower arches ii. About to debond iii. Planned for vacuum-formed retainers for retention iv. Non smoking patients v. No systemic disease
Key exclusion criteria (1 listed)
- Undergoing sectional fixed appliance / single arch treatment ii. Indicated for double retention regime with bonded retainers iii. Patient with smoking habit iv. Any systemic disease that may affect the salivary flow v. History of use of antimicrobial mouthwash less than 1 month prior to debond
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 |
|---|---|---|
| Conventional VFRConventional retainers | Device | Conventional Vacuum-Formed Retainers |
| VFR from SLASLA has better finishing compared to FDM but it is more expensive. | Device | Vacuum-Formed Retainers From SLA |
| VFR from FDMFDM has poorer finishing compared to SLA but it is cheaper. | Device | Vacuum-Formed Retainers From FDM |
Primary outcome
Microbial Colonisation On Vacuum-Formed Retainers
Time frame: 6 months
Microbial colony count on the vacuum-formed retainers constructed on conventional models \& 3D reconstructed models. The vacuum-formed retainers that are collected from the patients will be placed in BHI media and then 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.
1 secondary outcome
Surface Roughness Of Vacuum-Formed Retainers
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Background: PubMed 2531176Dawes C, Watanabe S, Biglow-Lecomte P, Dibdin GH. Estimation of the velocity of the salivary film at some different locations in the mouth. J Dent Res. 1989 Nov;68(11):1479-82. doi: 10.1177/00220345890680110201.
- Background: PubMed 18460676Dawes C. Salivary flow patterns and the health of hard and soft oral tissues. J Am Dent Assoc. 2008 May;139 Suppl:18S-24S. doi: 10.14219/jada.archive.2008.0351.
- Background: PubMed 28459285Dietrich CA, Ender A, Baumgartner S, Mehl A. A validation study of reconstructed rapid prototyping models produced by two technologies. Angle Orthod. 2017 Sep;87(5):782-787. doi: 10.2319/01091-727.1. Epub 2017 May 1.
- Background: PubMed 24373661Hazeveld A, Huddleston Slater JJ, Ren Y. Accuracy and reproducibility of dental replica models reconstructed by different rapid prototyping techniques. Am J Orthod Dentofacial Orthop. 2014 Jan;145(1):108-15. doi: 10.1016/j.ajodo.2013.05.011.
- Background: PubMed 19486368Hibino K, Wong RW, Hagg U, Samaranayake LP. The effects of orthodontic appliances on Candida in the human mouth. Int J Paediatr Dent. 2009 Sep;19(5):301-8. doi: 10.1111/j.1365-263X.2009.00988.x. Epub 2009 Apr 16.
- Background: PubMed 17702797Hichens 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.
- Background: PubMed 23721330Kasparova M, Grafova L, Dvorak P, Dostalova T, Prochazka A, Eliasova H, Prusa J, Kakawand S. Possibility of reconstruction of dental plaster cast from 3D digital study models. Biomed Eng Online. 2013 May 31;12:49. doi: 10.1186/1475-925X-12-49.
- Background: PubMed 18809782Keating AP, Knox J, Bibb R, Zhurov AI. A comparison of plaster, digital and reconstructed study model accuracy. J Orthod. 2008 Sep;35(3):191-201; discussion 175. doi: 10.1179/146531207225022626.
- Background: PubMed 26957903Kim GB, Lee S, Kim H, Yang DH, Kim YH, Kyung YS, Kim CS, Choi SH, Kim BJ, Ha H, Kwon SU, Kim N. Three-Dimensional Printing: Basic Principles and Applications in Medicine and Radiology. Korean J Radiol. 2016 Mar-Apr;17(2):182-97. doi: 10.3348/kjr.2016.17.2.182. Epub 2016 Mar 2.
- Background: PubMed 21187528Low B, Lee W, Seneviratne CJ, Samaranayake LP, Hagg U. Ultrastructure and morphology of biofilms on thermoplastic orthodontic appliances in 'fast' and 'slow' plaque formers. Eur J Orthod. 2011 Oct;33(5):577-83. doi: 10.1093/ejo/cjq126. Epub 2010 Dec 27.
- Background: PubMed 27011935Mamai-Homata E, Koletsi-Kounari H, Margaritis V. Gender differences in oral health status and behavior of Greek dental students: A meta-analysis of 1981, 2000, and 2010 data. J Int Soc Prev Community Dent. 2016 Jan-Feb;6(1):60-8. doi: 10.4103/2231-0762.175411.
- Background: PubMed 8615947Marsh PD. The role of microbiology in models of dental caries. Adv Dent Res. 1995 Nov;9(3):244-54; discussion 255-69. doi: 10.1177/08959374950090030901.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional VFR, VFR from SLA and VFR from FDM in people with Orthodontic Appliance Complication, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 May 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial Colonisation On Vacuum-Formed Retainers (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 NCT03844425, which also lists 18 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 26 May 2021; AzTrials last refreshed its copy on 30 Oct 2026.