Efficacy of the Disclosing Plaque Agent as a Guide to Remove the Oral Biofilm in Orthodontic Pati… (NCT05428189) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of the Disclosing Plaque Agent as a Guide to Remove the Oral Biofilm in Orthodontic Patients.
Italy32 participantsStarted 2020-10-10
Plain-language summary
It is more difficult to perform excellent professional oral hygiene in patients wearing orthodontic appliances.
The hypothesis of the present randomized controlled trial is that the application of plaque disclosing agent allows better biofilm removal.
To test this hypothesis, the patients, upon initial evaluation, will be divided in 2 study groups:
* CONTROL GROUP will receive professional oral hygiene without disclosing agent
* TEST GROUP will receive professional oral hygiene guided by plaque disclosing agent
At the end of the professional oral hygiene session, the disclosing agent is re-applied in all patients and the percentage of residual plaque area is calculated though image software analysis (ImageJ).
Who can participate
Age range
18 Years – 75 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:
* Signed Informed Consent Form;
* Male and female subjects, aged 18-75 years, inclusive;
* Presence of orthodontic appliances;
* Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives);
* Generalized gingivitis;
* Plaque index (PI) above 25%;
* Availability for session of the study for an assigned subject;
* Presence of all inferior and superior anterior teeth from canine to canine;
* Smoking less than 10 cigarettes a day.
Exclusion Criteria:
* Chronic obstructive pulmonary disease and asthma;
* Patients with periodontally disease defined as presence of PPD \>= 4mm and /or PAL of \>=3m;
* Splinted teeth;
* Presence of prosthesis;
* Tumors or significant pathology of the soft or hard tissues of the oral cavity;
* Current radiotherapy or chemotherapy;
* Pregnant or lactating women;
* History of allergy to Erythritol;
* History of adverse reactions to lactose or fermented milk products;
* Restorations on the teeth to be treated which may interfere with treatment administration and/or scoring procedures, at the discretion of the examiner;
* Not willing to follow the agreed protocol.
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
1
Residual Plaque Area (RPA)
Timeframe: At the end of the treatment session
Trial details
NCT IDNCT05428189
SponsorAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia