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

NCT05355740 | Unknown FDA Drug

• 1 other identifier: 0694-21-RMB CTIL
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Periodontitis; Subgingival Plaque

Keywords

chlorhexidine; subgingival plaque

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Corsodyl DRUG

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (2)

Rambam Health Care Campus

Haifa, 3109601, Israel

RECRUITING

Rambam Health Care Campus

Haifa, 31096, Israel

RECRUITING

MeSH Terms

Conditions

Periodontitis

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Jacob Horwitz, DMD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liron Eliezer

CONTACT

+972 4 7772983; l_eliezer@rambam.health.gov.il

Jacob Horwitz, DMD

CONTACT

+972 4 7772983; j_horwitz@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director-Graduate Program in Periodontology

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 2, 2022
• Study Start: February 3, 2023
• Primary Completion: June 10, 2024
• Study Completion: June 25, 2024
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)