Randomized Controlled Clinical Trial Of Oral Health-Related Quality Of Life In Patients Wearing Vacuum Formed Thermoplastic Retainers Constructed On Conventional Stone Models And On 3D Reconstructed Orthodontic Study Model
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ClinicalTrials.gov Identifier: NCT02866617 |
Recruitment Status :
Completed
First Posted : August 15, 2016
Last Update Posted : April 9, 2018
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In dentistry, 3D printing technology is gaining interest. One of the potential application is to construct appliances on 3D reconstructed study models.
The purpose of this study is to compare vacuum formed thermoplastic orthodontic retainers (VFR) constructed on conventional orthodontic study models and reconstructed 3D study models by assessing the oral health-related quality of life (OHRQoL) instrument, Little's Irregularity Index (LII) and compliance.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Quality of Life | Device: Vacuum Formed Thermoplastic Retainers Constructed On 3D Reconstructed Orthodontic Study Model | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Other |
Actual Study Start Date : | October 2015 |
Actual Primary Completion Date : | January 30, 2017 |
Actual Study Completion Date : | March 30, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Conventional
T1-T2 : VFR constructed on conventional study model T2-T3 : VFR constructed on 3D reconstructed study model
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Device: Vacuum Formed Thermoplastic Retainers Constructed On 3D Reconstructed Orthodontic Study Model |
Experimental: 3D
T1-T2 : VFR constructed on 3D reconstructed study model T2-T3 :VFR constructed on conventional study model
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Device: Vacuum Formed Thermoplastic Retainers Constructed On 3D Reconstructed Orthodontic Study Model |
- Oral Health-Related Quality Of Life [ Time Frame: 6 month ]
- Little's Irregularity Index [ Time Frame: 6 month ]
- Patient's compliance on wearing orthodontic retainers [ Time Frame: 6 month ]A survey of patient's compliance wearing the orthodontic retainers in 6 months

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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Inclusion criteria
- fixed appliance treatment following both arches;
- indicated for vacuum formed thermoplastic retainers as retention phase in treatment plan;
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Exclusion criteria:
- single-arch or sectional fixed appliance treatment,
- hypodontia requiring tooth replacement on the retainer as a temporary measure,
- undergone rapid maxillary expansion,
- indicated for double retention regime (bonded retainers),
- early debonding patients.
- patients intending to relocate within the study period
- patient with learning difficulties and can't read written instructions/questionnaire in English or Malay
- patient with cleft lip or palate
- has undergone surgical treatment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866617
Malaysia | |
Faculty of Dentistry, University of Malaya | |
Kuala Lumpur, Malaysia, 50603 |
Principal Investigator: | Wan Nurazreena Wan Hassan, BDS | University of Malaya |
Responsible Party: | University of Malaya |
ClinicalTrials.gov Identifier: | NCT02866617 |
Other Study ID Numbers: |
PPPC/C1-2015/DGD/12 |
First Posted: | August 15, 2016 Key Record Dates |
Last Update Posted: | April 9, 2018 |
Last Verified: | April 2018 |
Quality of Life Vacuum formed thermoplastic retainer Orthodontic study model 3D reconstructed study model |