CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Conventional VFR +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03844425
NCT03844425N/ACompleted

Microbial Colonisation On Vacuum-Formed Retainers With Different Surface Roughness As Constructed On Conventional Models And Three Dimensional (3D) Reconstructed Models

University of Malaya·interventional·Posted Feb 18, 2019·Updated May 26, 2021

In Brief

A clinical study evaluating Conventional VFR, VFR from SLA, and 1 other intervention for Orthodontic Appliance Complication. Completed, enrolled 36 participants across 1 site.

Detailed 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. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMalaysia
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 18, 2019
Enrollment StartDec 2, 2019
Primary CompletionApr 10, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.4 years ago

Interventions

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.