CompletedNot Applicable

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

Malaysia36 participantsStarted 2019-12-02

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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 Exclusion Criteria: 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Microbial Colonisation On Vacuum-Formed Retainers

Timeframe: 6 months

Trial details

NCT IDNCT03844425

SponsorUniversity of Malaya

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04-10

View on ClinicalTrials.gov More Orthodontic Appliance Complication trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.