The Effect of Oral Antiseptic Gargles on the Oral Cavity Microbiome

Oral Health Clinical Trial

Official title: The Effect of Oral Antiseptic Gargles on the Oral Cavity Microbiome

Status Completed

Clinical Trial Summary

This study determines the effects of a single dose of different antiseptic mouth washes within the oral cavity, on the composition of the oral microbiome using next generation sequencing (NGS) techniques. Twelve healthy volunteers will receive all three test products in a randomized order to compare the effects of each mouth wash.

Clinical Trial Description

Disinfectants and oral antiseptics including PVP-I are known to kill microorganisms to a variable extent, at a variable range of time points. Microorganisms may be protected from disinfectants by production of thick masses of cells and extracellular materials, or biofilms. Moreover, antiseptics should not lead to dysbiosis after use. Dysbiosis is a negative change in the microbiome of a particular skin or mucosal region. The Human Microbiome project showed, that every area has a specific microbiota in which the human host lives with an abundance of commensal, synergistic, and potentially pathogenic microorganisms. Antiseptics with efficacy gaps and resistance may induce such dysbiosis, especially after prolonged use.

It is envisaged that twelve healthy volunteers will complete the study. Each healthy volunteer will rinse with the test product according to a developed protocol, between established wash out periods.

The ability of the test product (1% Betadine® PVP-I based mouth wash and gargle) compared to the reference products (0.2% Chlor-Rinse™ Chlorhexidine based mouth wash (No alcohol) and Normal saline gargle) to reduce resident and transient microflora will be assessed. The mouth wash products will also be assessed for their ability to maintain and/or restore balanced microflora. ;

Related Conditions & MeSH terms

• Oral Health

• NCT number: NCT03141554
• Study type: Interventional
• Source: Mundipharma Manufacturing Pte Ltd.
• Status: Completed
• Phase: Phase 4
• Start date: May 5, 2017
• Completion date: May 19, 2017