Salivary Microbiota and Antimicrobial Resistance in Relation to Chlorhexidine Use (NCT07570927) | Clinical Trial Compass
CompletedNot Applicable
Salivary Microbiota and Antimicrobial Resistance in Relation to Chlorhexidine Use
Czechia11 participantsStarted 2022-04-11
Plain-language summary
This study evaluated the ecological effects of 0.06% chlorhexidine toothpaste on the salivary microbiota of healthy individuals, focusing on taxonomic composition, functional shifts, and prevalence of predicted antimicrobial resistance genes. Saliva samples were collected from eleven healthy participants at three specific time points: baseline (following a 4-week run-in period using a control toothpaste), intervention (after 12 weeks of using 0.06% chlorhexidine digluconate toothpaste), and washout (after a subsequent 12-week period using the control toothpaste). Sequencing targeted the 16S rRNA V3-V4 region.
Who can participate
Age range
25 Years – 44 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:
* Age: Between 25-44 years.
* General Health: Good systemic health (absence of chronic inflammatory diseases or conditions affecting oral tissues).
* Oral Hygiene Routine: Participants must perform toothbrushing twice a day and use interdental cleaning aids once a day.
* Plaque Index (PI): A score of 0.0-0.2 according to Silness and Löe.
* Gingival Index (GI): A score of 0.0-0.143 according to Silness and Löe.
Exclusion Criteria:
Systemic and Lifestyle Factors:
* Presence of any chronic systemic disease (e.g., diabetes mellitus, autoimmune disorders)
* Regular use of medications that may affect gingival status or saliva production.
* Use of antibiotics within the last 6 months prior to the study.
* Current pregnancy or lactation.
* Current smokers or users of other tobacco/nicotine products.
Oral and Dental Factors:
* Active dental disease: Presence of untreated tooth decay, gingivitis (GI \> 0.143), or any form of periodontitis.
* Prosthetics and Implants: Presence of dental implants, dentures, or significant tooth loss (excluding extracted third molars).
* Ongoing fixed or removable orthodontic treatment.
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
Change in Salivary Microbial Alpha Diversity (Shannon and Simpson Indices)
Timeframe: Baseline (week 0), after intervention (week 12), and after washout (week 24).
2
Change in Salivary Microbial Beta Diversity (Community Structure)
Timeframe: Baseline (week 0), after intervention (week 12), and after washout (week 24).