The Effect of Oral Antiseptic Gargles on the Oral Cavity Microbiome

Mundipharma

Status and phase: Completed; Phase 4

Conditions: Oral Health

Treatments: Drug: 1% Betadine® PVP-I based mouth wash and gargle,; Drug: Normal saline gargle; Drug: 0.2% Chlor-Rinse™ Chlorhexidine based mouth wash

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03141554

BTD16-SG-401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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12 participants in 3 patient groups

Treatment Sequence Group 1

Active Comparator group

Description:

Treatment Sequence Group 1 = A -\> B -\> C Treatment A = 1% Betadine® PVP-I based mouth wash and gargle Treatment B = 0.2% Chlor-Rinse™ Chlorhexidine based mouth wash (no alcohol) Treatment C = Normal saline gargle (lukewarm).

Treatment:

Drug: 0.2% Chlor-Rinse™ Chlorhexidine based mouth wash

Drug: Normal saline gargle

Drug: 1% Betadine® PVP-I based mouth wash and gargle,

Treatment Sequence Group 2

Active Comparator group

Description:

Treatment Sequence Group 2 = B -\> C -\> A Treatment B = 0.2% Chlor-Rinse™ Chlorhexidine based mouth wash (no alcohol) Treatment C = Normal saline gargle (lukewarm). Treatment A = 1% Betadine® PVP-I based mouth wash and gargle

Treatment:

Drug: 0.2% Chlor-Rinse™ Chlorhexidine based mouth wash

Drug: Normal saline gargle

Drug: 1% Betadine® PVP-I based mouth wash and gargle,

Treatment Sequence Group 3

Active Comparator group

Description:

Treatment Sequence Group 3 = C -\> A -\> B Treatment C = Normal saline gargle (lukewarm). Treatment A = 1% Betadine® PVP-I based mouth wash and gargle Treatment B = 0.2% Chlor-Rinse™ Chlorhexidine based mouth wash (no alcohol)

Treatment:

Drug: 0.2% Chlor-Rinse™ Chlorhexidine based mouth wash

Drug: Normal saline gargle

Drug: 1% Betadine® PVP-I based mouth wash and gargle,