Open-label Trial Evaluating Four Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste, and… (NCT05999175) | Clinical Trial Compass
CompletedNot Applicable
Open-label Trial Evaluating Four Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste, and Mouthwash
Italy84 participantsStarted 2022-05-17
Plain-language summary
The purpose of this open-label, randomized controlled clinical trial, is to provide preliminary clinical data (efficacy on plaque and gingival sensitivity, and safety and tolerability of two types of toothpaste, a mouthwash, and a specifically custom-designed toothbrush used for 28 days), as well as descriptive data on the effects of the products on oral microbiota rebalancing and patient acceptability. Eighty-four participants with a history of poor oral hygiene are visited at baseline and after 28 days of administration of the tested products. The control group consisted of 12 participants who continued to use their oral care products without changing their normal routine. At baseline and at the end of treatment (final visit), the oral microbiome is also evaluated in a group of 12 subjects allocated randomly.
Who can participate
Age range
18 Years – 65 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:
* Healthy Caucasian males and females aged ≥ 18 to ≤ 65 years included.
* Proper oral hygiene not performed verified with Simplified Oral Hygiene Index (OHI-S) (score ≥ 2) and a questionnaire on oral habit.
* Patients able to comply with the requirements for the study and freely willing to provide written informed consent to the collection of their data.
* Registered with Italian National Health Service (NHS).
* Ability to understand the language used in the investigation center and to comply with the study procedures.
* Unbanned pharmacological therapy stable for at least one month without any changes during the study.
* Commitment not to change the daily routine and lifestyle.
Exclusion Criteria:
* Allergies or sensitivity to oral care products, cosmetic products, drugs, patch or medical devices.
* Any oral cavity condition inappropriate for participation.
* Gums bleeding due to pathologies/pharmacological treatment.
* Concomitant or during the last week antibiotic therapy.
* Smokers (≥5 cigarettes/day).
* Acute, chronic or progressive diseases/illness/conditions able to interfere with the outcome of the study or considered dangerous or incompatible with the study requirements.
* Pathological staining of teeth.
* Breast-feeding, pregnancy, or women of child-bearing age unwilling to take the necessary precautions to avoid pregnancy during the study.
* Planning to participate or participation in other clinical trials withing 30 days.
* Hospitalization/p…
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.