Comparative Effects of Two Oral Antiseptics Used as an Adjuvant in the Treatment of Periodontitis (NCT06967402) | Clinical Trial Compass
RecruitingNot Applicable
Comparative Effects of Two Oral Antiseptics Used as an Adjuvant in the Treatment of Periodontitis
Hong Kong60 participantsStarted 2025-11-20
Plain-language summary
The focus of this study is on two types of mouthwashes - one containing a chlorhexidine (CHX) at 0.2% (CHX), and the other one containing CHX at a lower concentration of 0.12% with cetylpyridinium chloride (CPC). Both mouthwashes are used to help in the treatment of gum disease. CHX has been known for a long time for its effectiveness against plaque and mouth inflammation. It could inhibit and even kill them. However higher concentrations of CHX comes with unwanted side effect including altered taste, teeth staining and irritation in the mouth. Interestingly, these side effects seem to occur less frequently when a lower concentration CHX solution is used. CPC also combats bacteria by adhering quickly to the surfaces inside your mouth, although it has less substantivity than CHX, it has been shown to reduce plaque and gum inflammation effectively, and it typically causes fewer side effects than CHX. We hypothesize that this new formulation of CHX 0.12%+CPC mouthwash is non-inferior to CHX 0.2% in terms of its anti-plaque and anti-inflammatory properties while presenting with less side effects after 21 days of use. Microbiological samples and fluids from periodontal pockets will be collected before and after treatment for analysis of microbiological effects.
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Consenting patients with at least 6 evaluable teeth in each quadrant, including minimum 1 molar and 1 premolar.
* Generalized stage II-III periodontitis patients.
* Baseline BOP \> 25%.
* No known allergy or adverse effects to CHX or CPC
* Non-smokers, non-orthodontic patients, no concurrent or past antibiotics/medication known to affect periodontal status (i.e. calcium antagonists, phenytoin)/anti-inflammatory therapy (i.e. NASIDs) in the last 3 months, pregnant/breastfeeding, compliance to study procedures.
* ASA class I-II patients.
* Either non-diabetic or with controlled diabetes (HbA1C\<7).
* Normal/Elevated blood pressure (AHA - Systolic \<130mmHg; Diastolic \<80mmHg).
* No radiation/chemotherapy in the past 5 years
* No immunosuppression including drug induced immunosuppression.
* No participation in other clinical studies in the last 4 weeks.
* No administration of CHX or CPC in the last 3 months
* No periodontal treatment in the last 3 months.
Exclusion Criteria:
* Unable to provide written consent.
* Non-compliant study procedures.
* Patients with medical (including psychiatric) and pharmacotherapeutic histories that, in the investigator's opinion, may compromise the protocol.
* Patients requiring antibiotics prophylaxis for dental procedures.
* Patients with self-reported pregnancy or patients who are breastfeeding.
* Patients with history of use of systemic antibiotics, in combination with any form of periodontal treatment, within the pas…
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.