Clinical Investigation of Bleeding Reduction Efficacy on Toothpaste Containing 1.05% Chitosan (NCT06955871) | Clinical Trial Compass
CompletedNot Applicable
Clinical Investigation of Bleeding Reduction Efficacy on Toothpaste Containing 1.05% Chitosan
China134 participantsStarted 2025-04-29
Plain-language summary
The purpose of this study is to assess the bleeding reduction efficacy of toothpaste containing 1.05% Chitosan compared to a regular fluoride toothpaste, and compared to a toothpaste containing 67% bicarbonate.
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
. Male or female subjects, aged 18-70, inclusive.
. Availability for the duration of the study.
. Ability to understand and willingness to read, and sign the Informed Consent Form after the nature of the study has been fully explained to them.
. Willingness to comply with all study procedures and clinical examination schedules.
. Good general health (absence of any condition that, in the opinion of the study examiner, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements etc).
. Presence of a minimum of 20 natural teeth (excluding third molars) with facial and lingual scoreable surfaces.
. Have a mean Modified Gingival Index (Lobene) ≥ 2.5 at screening.
. Subjects reporting bleeding while routine toothbrushing.
Exclusion criteria
. Pregnant or lactating.
. Use of tobacco products.
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
Gingival Bleeding
Timeframe: From baseline to 3 days, 7 days and 14 days after baseline.
2
Gingivitis
Timeframe: Baseline, and immediately post-brushing
. Medical condition (especially, heart or liver problems, bleeding disorders, blood dyscrasias) or any current usage of medication that the investigator considers may compromise the subject safety, as well as, the quality of the study results.
. Medical condition which requires pre-medication prior to dental visits/procedures.
. History of allergy to oral hygiene products.
. Use of anti-inflammatory, immunosuppressive, antimicrobial or anticoagulant drugs or antibiotics in the 30 days prior to the start of the study and during the course of the study.
. Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine).