UnknownNot Applicable

Effect of Enzyme-containing Mouth Rinse on Dental Biofilm in Patients With Fixed Orthodontic Appliances

Sweden40 participantsStarted 2021-03-01

Plain-language summary

Caries is a biofilm-mediated global public health problem causing health, social and economic consequences for individuals, communities and countries. Treatment with fixed orthodontic appliances is associated with impaired oral hygiene. This results in a demineralization of the enamel (white spot lesions). The prevalence is fairly high (30-50%) among adolescents and self-applied fluorides cannot completely prevent such lesions. It is therefore important to investigate novel approaches to combat these unwanted adverse effects. A systematic review has suggested that mouthwashes may be suitable technology to control biofilm accumulation in orthodontic patients. The aim of the present pilot study is to evaluate the effect of a novel mouth rinse containing a blend of natural enzymes in addition to fluoride on the presence of oral biofilm in patients undergoing treatment with fixed orthodontic appliances.

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: * patients with fixed orthodontic appliances in at least one arch for at least 3-6 months, * visible plaque around the bracket bases of at least 6 teeth * repeated oral hygiene instructions have been given during the orthodontic treatment Exclusion Criteria: * clinically visible active caries lesions and/or periodontitis * significant oral soft tissue pathology based on a visual examination * history of allergy or significant adverse events following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients * history of allergies to ingredients in the test product, including allergy against enzymes * history of common food allergies, such as peanuts, tree nuts, milk, eggs, shellfish, fish, wheat, soybeans * self-reported serious medical conditions, pregnancy or nursing * acute sinusitis or severe oral-pharyngeal infections

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

dental biofilm in test and control

Timeframe: 7 days

Trial details

NCT IDNCT05033015

SponsorMalmö University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-01

View on ClinicalTrials.gov More Caries 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.