The Effect of Post-surgical Chlorhexidine Mouth Washing on the Sub-gingival Periodontal Microbiome A Pilot Study (SUPEM1)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis; Subgingival Plaque
• Intervention / Treatment: Drug: Corsodyl

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Health Care Campus
    • Contact: Liron Eliezer; Phone Number: +97248542983; Email: l_eliezer@rambam.health.gov.il
  • Haifa, Israel, 31096
    • Recruiting
    • Rambam Health Care Campus
    • Contact: Jacob Horwitz, DMD; Phone Number: 972-4-854-2983
    • Principal Investigator: Jacob Horwitz, DMD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for periodontal surgery/dental extractions at the Rambam Department of Periodontology

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2023
• Primary Completion (Anticipated): June 10, 2024
• Study Completion (Anticipated): June 25, 2024

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: chlorhexidine; subgingival plaque
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: 0694-21-RMB CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No