Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial O… (NCT07501455) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
United States250 participantsStarted 2026-02-26
Plain-language summary
This study is a six-week, double-blind, randomized, parallel-group controlled clinical study. The objective of this study is to evaluate the changes to the oral microbiome, inflammatory mediators, gingival health indices and to assess oral tolerance after 4 weeks of twice daily use of differing oral hygiene regimens including mouthwash compared to a control group. A follow-up assessment will be completed 2 weeks after cessation of treatments.
Who can participate
Age range
18 Years – 60 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.
Exclusion criteria
. Significant oral soft tissue pathology or active dental caries, based on the dentist's visual examination and at the discretion of the Investigator.
. History of significant adverse reactions, including sensitivity or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses, and red food dye.
. Periodontitis, as determined by more than 2 sites with a probing depth greater than 4mm.
. Regular consumption of probiotics supplements within one week prior to screening. Subjects can be rescreened if they fulfill this criterion.
. Dental prophylaxis within 4 weeks prior to screening. Subjects can be rescreened if they fulfill this criterion.
. Subjects who wear orthodontic bands, fixed retainers, removable orthodontic appliances, clear aligners or night guards or subjects who have had significant (based on the examiner or PI's oral exam) cosmetic restorations.
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
Changes in profiles in supragingival plaque microbiome samples
Timeframe: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)