An observational study in Periodontitis and Subgingival Plaque, sponsored by Rambam Health Care Campus. Status unknown at 2 sites in Israel. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-30.
Sponsored by Rambam Health Care Campus · Observational
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.
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's planned enrollment of 30 is below the median of 90 across 428 observational studies indexed under Periodontitis.
Browse Periodontitis studies →Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.
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Patients scheduled for periodontal surgery/dental extractions at the Rambam Department of Periodontology
Exclusion Criteria:
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
Also known as: Chlorhexidine mouthwash
alpha and beta diversity
sub-gingival microbiome changes between pre- and post- mouthwash usage in non-surgical sites and in surgical sites
Time frame: 10-14 days
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Rambam Health Care Campus