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

Periodontitis Clinical Trial

— SUPEM1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05355740
• Other study ID #: 0694-21-RMB CTIL
• Status: Recruiting
• Start date: February 3, 2023
• Est. completion date: June 25, 2024

Study information

• Verified date: March 2023
• Source: Rambam Health Care Campus
• Contact: Liron Eliezer
• Phone: +972 4 7772983
• Email: l_eliezer[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 25, 2024
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis
• Subgingival Plaque

Intervention

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

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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