RecruitingNot ApplicableNCT06967402

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

Comparative Clinical Efficacy and Microbiological Effects of Two Oral Antiseptics Used as an Adjuvant in the Treatment of Severe Periodontitis


Sponsor

The University of Hong Kong

Enrollment

60 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria13

  • 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 Criteria9

  • 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.

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Interventions

OTHERExperimental (chlorhexidine)

Test group: administration of experimental antiseptic (CHX 0.12%+CPC 0.05%) for 3 weeks

OTHERControl (chlorhexidine with cetylpyridinium chloride)

Active comparator: administration of control antiseptic (CHX 0.2%) for 3 weeks


Locations(1)

HKU Faculty of Dentistry, IAD - Clinical Research Centre

Hong Kong, Hong Kong

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NCT06967402


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