Black Stains' Epidemiology, Clinical Evaluation and Dietary Habits: a Clinical Trial. (NCT04865796) | Clinical Trial Compass
CompletedNot Applicable
Black Stains' Epidemiology, Clinical Evaluation and Dietary Habits: a Clinical Trial.
Italy45 participantsStarted 2021-05-15
Plain-language summary
The aim of this study is to investigate epidemiology and treatment possibilities of black stains, with the assessment of a possible correlation with patients' dietary habits.
Patients will be randomly divided into three groups. For each group, clinical evaluation will be performed at the study begin, after 2 and after 6 months.
At the study begin, evaluation of black stains with Gasparetto's classification will be assessed; then professional oral hygiene with ultrasonic scaler will be performed, plus glycine and polish; then, products for home oral care will be given to patients, depending on the groups. The clinical situation will be re-evaluated after 2 and after 6 months. Home oral care will be performed with different products, containing lactoferrin (group 1) and probiotics (group 2). The control group (Group 3) will use normal products.
Who can participate
Age range
18 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:
* Adult patients with black stains
* Patients with high compliance
Exclusion Criteria:
* Patients suffering from psychological, neurological or psychiatric disorders
* Pregnant or breastfeeding women
* Patients undergoing anti-cancer therapy
* Patients with low compliance
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 focused on black stains on teeth and looked at dietary habits as a potential factor — based on what this study found, are there specific foods or drinks my doctor thinks I should change to help manage or prevent black stains?
2Since this trial measured how much the black stains changed over time using a specific scoring system, what do those kinds of results actually mean for my situation — are black stains considered a cosmetic issue, a sign of something else, or both?
3Now that this trial is completed, has the research produced any findings that my dentist or doctor thinks are relevant to how my child's or my own black stains should be treated or monitored?
4This study looked at the epidemiology of black stains, meaning how common they are and what might cause them — does my doctor think my case fits the typical pattern seen in studies like this, and does that affect the recommended approach?
5Are there standard dental treatments for black stains that my doctor would recommend first, and how does the evidence from an observational study like this one compare to what's already known about managing this condition?
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
1
Change in the extension of black stains (Gasparetto et al., 2003)