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

Study Overview
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Brief Summary
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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.

Detailed Description
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Microbial identification: periodontal samples will be collected by the GeneFiX™ Saliva DNA Microbiome Collection Device (Isohelix). DNA Extraction - the MagMAX Microbiome Ultra Nucleic Acid Isolation Kits (Termo Fisher). DNA yields and purity - measuring absorbance at 260 nm, A260/A280 and A260/A230 ratios with the Nano-drop 2000 spectrophotometer (Nanodrop products, Wilmigton,USA). Microbiome sequencing - target V4 region of 16s rRNA gene will be sequenced on the Ion Torrent S5 instrument (Thermofisher) and analysis will be performed with the ERGO 2.0 platform ( iGenbio). The investigators will perform comparisons of alpha and beta diversity before and after intervention, as well as differential abundance of the taxa.

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

Conditions
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Periodontitis, Subgingival Plaque

Intervention / Treatment
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* Drug: Corsodyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Corsodyl|Corsodyl (a chlorhexidine mouthwash) will be used to rinse the mouth for one minute with 10 ml twice daily during ten days after oral surgery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| alpha and beta diversity | sub-gingival microbiome changes between pre- and post- mouthwash usage in non-surgical sites and in surgical sites | 10-14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chlorhexidine, subgingival plaque