Clinical trial NCT05355740: The Effect of Post-surgical Chlorhexidine Mouth Washing on the Sub-gingival Periodontal Microbiome A Pilot Study
Official title: The Effect of Post-surgical Chlorhexidine Mouth Washing on the Sub-gingival Periodontal Microbiome; a Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis
Subgingival Plaque
Keywords: chlorhexidine
subgingival plaque
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for periodontal surgery/dental extractions at the Rambam Department of Periodontology

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.

Eligibility criteria: 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

Primary outcomes:
measure: alpha and beta diversity
timeFrame: 10-14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Jacob Horwitz, DMD
role: PRINCIPAL_INVESTIGATOR
References: