Microbial Colonisation On Vacuum-Formed Retainers Constructed On Conventional Models And Three Dimensional (3D) Reconstructed Models

NCT03844425 | Completed

• 1 other identifier: DGD_170002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orthodontic Appliance Complication

Keywords

Orthodontic Retainers; Printing, Three-Dimensional; Colony Count, Microbial

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Surface Roughness Of Vacuum-Formed Retainers

  6 months

Other Outcomes (1)

• Patient's Compliance In Wearing Vacuum-Formed Retainers

  6 months

Study Arms (3)

Conventional Vacuum-Formed Retainers

ACTIVE COMPARATOR

Vacuum-formed retainers constructed on conventional stone models.

Device: Conventional VFR

Vacuum-Formed Retainers From SLA

EXPERIMENTAL

Vacuum-formed retainers constructed on 3D reconstructed models using stereolitography (SLA) technique.

Device: VFR from SLA

Vacuum-Formed Retainers From FDM

EXPERIMENTAL

Vacuum-formed retainers constructed on 3D reconstructed models using fused deposition modeling technique (FDM).

Device: VFR from FDM

Interventions

Conventional VFR DEVICE

Conventional retainers

Conventional Vacuum-Formed Retainers

VFR from SLA DEVICE

SLA has better finishing compared to FDM but it is more expensive.

Vacuum-Formed Retainers From SLA

VFR from FDM DEVICE

FDM has poorer finishing compared to SLA but it is cheaper.

Vacuum-Formed Retainers From FDM

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• i. 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

You may not qualify if:

• i. 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Postgraduate Orthodontic Clinic, Faculty Of Dentistry, University Of Malaya

Kuala Lumpur, 50603, Malaysia

Location

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator will be masked with the randomization sequance \& allocation.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department Of Paediatric Dentistry & Orthodontics, Faculty Of Dentistry

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 18, 2019
• Study Start: December 2, 2019
• Primary Completion: April 10, 2021
• Study Completion: April 10, 2021
• Last Updated: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)