Air Polishers With Erythritol in the Treatment of Dental Black Stain of Bacterial Origin (NCT06720168) | Clinical Trial Compass
RecruitingNot Applicable
Air Polishers With Erythritol in the Treatment of Dental Black Stain of Bacterial Origin
Spain40 participantsStarted 2024-12-05
Plain-language summary
Black stains on the teeth, caused by the accumulation of chromogenic microorganisms that produce iron compounds, are more common in the pediatric population and have a negative impact on dental aesthetics and patients' self-esteem. The etiology of these stains remains unclear and is not related to oral hygiene. Currently, there is no definitive treatment that prevents the reappearance of these stains, and they can only be removed by mechanical removal, which can cause injuries to the tooth structure. This study aims to evaluate the effectiveness of erythritol powder air polishers, which have antimicrobial properties, compared to conventional prophylaxis in preventing the recurrence of stains.
A randomized clinical trial will be carried out with a follow-up of 12 months, during which patient satisfaction and duration of treatment will be assessed. The results of this study could provide valuable information to improve treatment and management strategies for dental stains in the affected population, thus contributing to the emotional well-being of patients and reducing damage to their tooth enamel.
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 2 or more teeth with black stain
Exclusion Criteria:
* Sistemic diseases
* Patients with physical and/or cognitive impairment which prevents participation in a dental prophylaxis.
* Use of oral antibiotics fifteen days before the intervention
* Allergy to erythritol
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.
1This trial is specifically about black stain caused by bacteria — how would my doctor confirm that my black stain is actually bacterial in origin before considering whether this trial might be relevant for me?
2The trial uses an air polisher with erythritol powder to treat black stain — how does this approach compare to the standard cleaning methods my dentist already uses, and are there any known risks to the tooth enamel or gums with air polishing?
3Since the main thing this trial is measuring is whether the black stain comes back after treatment, what would that follow-up process look like in terms of how many visits I'd need and over what period of time?
4This trial is listed as Phase NA, which often applies to device or procedure studies rather than drug trials — what does that mean for how much is already known about the safety and effectiveness of this specific air polishing approach?
5Are there standard dental treatments already available for bacterial black stain that my doctor would recommend trying first, and how would those compare to what's being tested in this trial?
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.