The Effect of Oral Antiseptic Gargles on the Oral Cavity Microbiome

• Status: Completed
• Trial end date: 2017-05-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mundipharma Manufacturing Pte Ltd.
• Collaborator: Singapore Polytechnic (SP)
• Treatments: Anti-Infective Agents, Local; Chlorhexidine; Chlorhexidine gluconate; Povidone-Iodine

Criteria

Inclusion Criteria:

• Male and female subjects 21 years and older,

• Not pregnant nor trying to conceive during the study period,

• Non-smoker, non-tobacco user (no chewing of tobacco or similar products),

• No systemic or topical oral antibiotic or antifungal in the past 2 months (from date of consent),

• No ongoing medication (e.g., immunosuppressive medication, no systemic or inhaled glucocorticoids),

• Prepared to use a toothpaste that does not any antimicrobials (Colgate Maximum Cavity Protection) for 2 days after providing consent and during the study,

• Prepared to refrain from using mouth washes/gargles or any other oral hygiene product for 2 days after providing consent and during the study,

• Good oral health (e.g., no visible bleeding, inflammation, oral ulcer or oral lesion, no need for dental treatment),

• Must have given written informed consent.

Exclusion Criteria:

• Allergy or contraindication to any test product substance (active or excipients),

• Known hyperthyroidism,

• Consumption of alcoholic beverages 24 hours before test product administration on Day 0, Day 2, and Day 4,

• Wearing dental appliances (all types of braces, removable or fixed dentures, etc.),

• Minor ailments like cough, cold, upper respiratory tract infection(s), or oral ulcer(s),

• Unwillingness or inability to comply with the requirements of the protocol,

• Participation in any other drug, biologic, device, or clinical study or treatment with any investigational drug or approved therapy for investigational use within 30 days (or 5 half-lives, whichever is longer) prior to the screening visit.