Periodontitis, Subgingival Plaque
Conditions
Keywords
chlorhexidine, subgingival plaque
Brief summary
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
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.
Interventions
DRUGCorsodyl
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
Sponsors
Rambam Health Care Campus
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| alpha and beta diversity | 10-14 days | sub-gingival microbiome changes between pre- and post- mouthwash usage in non-surgical sites and in surgical sites |
Countries
Israel
Contacts
Primary ContactLiron Eliezer
Backup ContactJacob Horwitz, DMD
Outcome results
None listed