Ozone Application Before Fissure Sealants (NCT04040920) | Clinical Trial Compass
RecruitingNot Applicable
Ozone Application Before Fissure Sealants
Italy67 participantsStarted 2019-06-17
Plain-language summary
Decay is a multifactorial infective degenerative disease of hard dental tissues, caused by Streptococcus mutans and Lactobacillus forming the bacterial biofilm of teeth surfaces. Decays generally evolve in fissures and pits of secondary molars. Pits and fissure sealants prevent decays if performed in two years from eruption. Ozone has bactericidal effect and remineralizing capacity on enamel.
The aim of this study is to assess the effectiveness of ozone application before sealants in increasing their duration in time.
Who can participate
Age range
6 Years – 16 Years
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:
* first or second secondary molars to be sealed
* possibility to isolate with rubber dam both the teeth involved
* no clear signs of pigmentations
* good general health
Exclusion Criteria:
* latex allergy
* epilepsy or other severe neurological pathologies
* psychiatric disease
* excessive sensibility to electrical current
* severe asthma
* enamel disorders, such as amelogenesis imperfect, white spots, fluorosis or Molar Incisors Hypomineralization
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.