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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Hong Kong Special Administrative Region
HKU Faculty of Dentistry, IAD - Clinical Research Centre
RECRUITING
Hong Kong
Contact Information
Primary
Melissa Fok, BDS, MDS (Perio), PhD
melfok@hku.hk
+85228590495
Backup
Amy Wong
ammmymei@hku.hk
85228590485
Time Frame
Start Date: 2025-11-20
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 60
Treatments
Active_comparator: Active control
CHX 0.2%
Experimental: Experimental
CHX 0.12%+CPC 0.05%
Related Therapeutic Areas
Sponsors
Leads: The University of Hong Kong
Collaborators: Dentaid SL

This content was sourced from clinicaltrials.gov