Effects of Two Daily CHX Mouthrinses on Plaque, Gingivitis and Staining (NCT07351370) | Clinical Trial Compass
CompletedPhase 3
Effects of Two Daily CHX Mouthrinses on Plaque, Gingivitis and Staining
Greece81 participantsStarted 2022-01-15
Plain-language summary
Τhe aim of this randomized clinical trial was to investigate the efficacy of two daily mouth rinses containing CHX and different combinations of H2O2 and CPC, when used adjunctive to mechanical oral hygiene, and compare them with a placebo mouth rinse. The primary outcomes evaluated were changes in i) bacterial biofilm accumulation, ii) gingival inflammation, and iii) tooth staining. Secondarily, patient's satisfaction and perspective after the use of these formulations was assessed.
Who can participate
Age range
18 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:
* Adult patients (≥18 years old)
* Presence of at least 24 teeth
* Presence of teeth #23-13 and #43-33
* Gingival Index (GI) ≤30% (Lindhe, 1981)
* No interdental clinical attachment loss (CAL) at ≥2 non-adjacent teeth or buccal/oral CAL ≥3 mm with probing pocket depth (PPD) \>3 mm at ≥2 teeth (Tonetti et al., 2019)
* No known allergy to chlorhexidine (CHX), hydrogen peroxide (H₂O₂), or cetylpyridinium chloride (CPC)
* No fixed or removable orthodontic appliances or removable prostheses
* No use of systemic antibiotics within the 3 months prior to the study
* Non-smokers or light smokers (\<5 cigarettes/day)
* Non-pregnant and non-lactating women
* Absence of crowns, fixed partial dentures, or class III/IV/V composite restorations covering more than one-third of the crown, and no deep dental caries extending into dentine
Exclusion Criteria:
* Presented with signs of hypersensitivity, severe irritation, or discomfort during the experimental period
* Were not compliant with the experimental protocol
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 plaque index (PI)
Timeframe: baseline, 1 month, 2 months and 3 months