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

Last updated: March 29, 2023
Sponsor: Rambam Health Care Campus
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

N/A

Clinical Study ID

NCT05355740
0694-21-RMB CTIL
  • Ages 18-99
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed Informed Consent Form
  • Age ≥18 years
  • Scheduled for periodontal/dental surgery without pre- and/or post-surgical antibiotictherapy

Exclusion

Exclusion Criteria:

  • Pre-existing conditions that may affect the microbiome, including diagnoses ofdiabetes, malignancy, alcoholism, previous head and neck radiation therapy
  • Pregnancy and breast-feeding
  • Chronic medications that are known to affect periodontal tissues such as Ca channelblockers 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

Study Design

Total Participants: 30
Study Start date:
February 03, 2023
Estimated Completion Date:
June 25, 2024

Study 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.

Connect with a study center

  • Rambam Health Care Campus

    Haifa, 3109601
    Israel

    Active - Recruiting

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