The Effect of Post-surgical Chlorhexidine Mouth Washing on the Sub-gingival Periodontal Microbiome; a Pilot Study

0694-21-RMB CTIL

Prospective applicants who conform with inclusion and exclusion criteria will be accepted into the study and sign a consent form. Visit 1: After initial screening a case report form (CRF) will be filled, including information regarding general health, medication, demographic, oral and dental information. Participants will be clinically examined and the following data will be collected prior to surgery: microbial collection, Plaque score (PS) , probing pocket depth (PPD), bleeding on probing (BOP) at selected non-surgical and surgical teeth. Surgery will be performed followed by discharge with a bottle of chlorhexidine mouthwash and written instructions on its usage. Visit 2: Ten days after surgery sutures will be removed and collected for microbial examination. Microbial collection will be performed at non-surgical and surgical sites. Adverse events will be recorded and participants will be discharged from the study.

2023-02-03

2024-06-10

2024-06-25

Recruiting

30

Inclusion Criteria: * Signed Informed Consent Form * Age ≥18 years * Scheduled for periodontal/dental surgery without pre- and/or post-surgical antibiotic therapy Exclusion Criteria: * Pre-existing conditions that may affect the microbiome, including diagnoses of diabetes, malignancy, alcoholism, previous head and neck radiation therapy * Pregnancy and breast-feeding * Chronic medications that are known to affect periodontal tissues such as Ca channel blockers and phenytoin * Antibiotic therapy within the previous 6 weeks * Mouthwash therapy within the previous 2 weeks * Known allergy to CM or any of its constituents * Smoking \>10 cigarettes/day

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2023-03-30