Clinical trial NCT03141554: The Effect of Oral Antiseptic Gargles on the Oral Cavity Microbiome
Official title: The Effect of Oral Antiseptic Gargles on the Oral Cavity Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oral Health
Lead sponsor: Mundipharma Manufacturing Pte Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Singapore Polytechnic (SP)
First posted: 2017-05-05
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 12 healthy volunteers will be randomized into 3 arms with 3 different treatment sequences with 4 healthy volunteers in each arm.
Primary purpose: PREVENTION

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Composition of oral microbiome - reduction of microflora
timeFrame: Swab 1 - 0 Min, Swab 2 - 3 min (post treatment) and Swab 3 - 240 min (post treatment)
measure: Composition of oral microbiome - maintenance of healthy microflora
timeFrame: Swab 1 - 0 Min, Swab 2 - 3 min (post treatment) and Swab 3 - 240 min (post treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore Hospital
Study officials:
References: