Clinical Efficacy of the Combined Effect of Oral Irrigator and Chemicals (0.075% CPC) (NCT06607172) | Clinical Trial Compass
CompletedPhase 3
Clinical Efficacy of the Combined Effect of Oral Irrigator and Chemicals (0.075% CPC)
Brazil30 participantsStarted 2024-09-30
Plain-language summary
This is an experimental gingivitis clinical study to evaluate gum health efficacy from the combination effect of water flosser and chemistry (0.075% CPC) compared to water flosser and water and to no oral hygiene regimen with a 3-week follow-up. Thirty participants, aged between 18 and 70, will be enrolled.
Who can participate
Age range
18 Years – 70 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;
* Aged between 18 and 70;
* Available for the three (3) week study duration;
* Good general health for participation in the study, based on the opinion of the study investigator;
* Must have at least 20 natural permanent teeth;
* Teeth must meet the scoring entry criteria for dental plaque and gingivitis (gum inflammation) at the discretion of the study examiner.
Exclusion Criteria:
* Medical condition which requires premedication prior to dental visits/procedures;
* Presence of fix/ removable prosthodontics dentures that may interfere with this study clinical examinations;
* Advanced periodontal disease (gum disease) and/or treatment for periodontal disease (including surgery) within the past twelve months;
* Five (5) or more decayed, untreated dental sites (cavities) and/or any dental condition requiring urgent dental care;
* Abnormalities/diseases of the soft or hard oral tissues;
* Orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring)
* Use of drugs that can affect salivary flow;
* Use of antibiotics three (3) months prior to study entry and/or during participation in this study;
* Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion;
* Self-reported pregnancy and/or breastfeeding;
* Current Participation in another clinical study or during the month prior to this clinical study entry;
* Known allergies and/o…
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.