Comparative Effects of Two Oral Antiseptics Used as an Adjuvant in the Treatment of Periodontitis
Recruiting now · Not applicable
Conditions studied: Periodontitis, Periodontitis Stage II, Periodontitis Stage III
In brief
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.
Key facts
- Study ID
- NCT06967402
- Run by
- The University of Hong Kong
- People needed
- 60
- Starts
- 2025-11-20
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-06-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- HKU Faculty of Dentistry, IAD - Clinical Research Centre — Hong Kong, Hong Kong (enrolling)
Full record on ClinicalTrials.gov
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