Two mouthwashes for gum disease: CHX 0.2% versus CHX 0.12% + CPC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with generalized stage II–III periodontitis will use a mouthwash as an adjunct to initial periodontal therapy. The study compares CHX 0.2% (control) to CHX 0.12% plus CPC 0.05% (experimental) over about 2 months, assessing inflammation, plaque, and microbiology, as well as patient-reported outcomes. Primary outcome is changes in full mouth bleeding on probing at 2 months after 21 days of daily use. Secondary outcomes include gingival indices, plaque indices, pocket depth, clinical attachment level, microbiological changes, tongue coating and staining, taste irritation, and safety signals.

Why it matters

Who can join: the full rules

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 past 3 months.
* Patients with uncontrolled endocrine disease.
* Patients who are not compliant with the review protocol, leading to deviation of more than 1 week.
* Patients requiring the admission of systemic antibiotics, in combination with any form of dental treatment, during the study period.

Where it's running

• HKU Faculty of Dentistry, IAD - Clinical Research Centre
  Hong Kong, Hong Kong Recruiting

Study contacts

• Study coordinator: Melissa Fok, BDS, MDS (Perio), PhD
• Email: melfok@hku.hk
• Phone: +85228590495

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.