Status:
NOT_YET_RECRUITING
Comparative Effects of Two Oral Antiseptics Used as an Adjuvant in the Treatment of Periodontitis
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Dentaid SL
Conditions:
Periodontitis
Periodontitis Stage II
Eligibility:
All Genders
18+ years
Phase:
NA
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 chl...
Detailed Description
* Aim: To compare the effects of 2 formulations of antiseptics on clinical efficacy (reduction of gingival inflammation and plaque) and oral microbiome when used as an adjuvant in periodontal treatmen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06967402
Start Date
July 1 2025
End Date
December 1 2026
Last Update
May 13 2025
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