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

NCT06967402 | Not Yet Recruiting

• 1 other identifier: P&ID2025-01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Periodontitis; Periodontitis Stage II; Periodontitis Stage III

Keywords

Mouthwash; Chlorhexidine; CPC; Periodontitis; Mouthrinse; cetylpyridinium chloride; Oral antiseptic

Outcome Measures

Primary Outcomes (1)

• % Bleeding on probing (BoP)

  % BoP will be assessed at 6 surfaces (mesiobuccal, mid buccal, disto-buccal, mesio-oral, mid-oral, disto-oral.) in a dichotomous manner (Mühlemann \& Son, 1971). Bleeding will be positive after 15 seconds of probing the gingival sulcus to the most apical stop. The percentage of the full mouth BoP will be reported.

  2 months

Secondary Outcomes (12)

• % Bleeding on probing (BoP)

  21 days

• Macpherson modification of the Lobene Stain Index (MLSI)

  21 days and 2 months

• Full mouth plaque score

  21 days and 2 months

• Clinical attachment level

  2 months

• Pocket probing depth (PPD)

  2 months

Study Arms (2)

Active control

ACTIVE COMPARATOR

CHX 0.2%

Other: Control (chlorhexidine with cetylpyridinium chloride)

Experimental

EXPERIMENTAL

CHX 0.12%+CPC 0.05%

Other: Experimental (chlorhexidine)

Interventions

Experimental (chlorhexidine) OTHER

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

Experimental

Control (chlorhexidine with cetylpyridinium chloride) OTHER

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

Active control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Dentaid SL: collaborator

MeSH Terms

Conditions

Periodontitis

Interventions

Chlorhexidine; Cetylpyridinium

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Pyridinium Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Melissa Fok, BDS, MDS (Perio), PhD

CONTACT

+85228590495; melfok@hku.hk

Amy Wong

CONTACT

85228590485; ammmymei@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The allocation concealment will be maintained from all parties until data analysis stage.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized double blinded non-inferiority controlled trial

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 13, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share