๐ฌIn plain words
What the trial is, and whether it could suit you
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 effect
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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\<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 Criteria:
* 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.
๐
What it tests
- Experimental (chlorhexidine)
- Control (chlorhexidine with cetylpyridinium chloride)
HKU Faculty of Dentistry, IAD - Clinical Research Centre
Hong Kong, Hong Kong
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.