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Recruiting NCT06967402

Comparative Effects of Two Oral Antiseptics Used as an Adjuvant in the Treatment of Periodontitis

Conditions: Periodontitis, Periodontitis Stage II, Periodontitis Stage III

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: The University of Hong Kong

Location: HKU Faculty of Dentistry, IAD - Clinical Research Centre Hong Kong

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.

Eligibility Criteria

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\

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Source: ClinicalTrials.gov (NCT06967402). StuddyBuddy aggregates publicly available trial information.