NCT03141554

The Effect of Oral Antiseptic Gargles on the Oral Cavity Microbiome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Mundipharma Manufacturing Pte Ltd. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Oral Health

Interventions

Type	Name	Description
DRUG	1% Betadine® PVP-I based mouth wash and gargle,	1% Betadine® PVP-I based mouth wash and gargle
DRUG	0.2% Chlor-Rinse™ Chlorhexidine based mouth wash	0.2% Chlor-Rinse™ Chlorhexidine based mouth wash
DRUG	Normal saline gargle	Normal saline gargle

Timeline

• Start date: 2017-05-05
• Primary completion: 2017-05-19
• Completion: 2017-05-19
• First posted: 2017-05-05
• Last updated: 2017-06-06

Locations

1 site across 1 country: Singapore