The Effect of Oral Antiseptic Gargles on the Oral Cavity Microbiome

NCT03141554 | Completed Phase 4

• 1 other identifier: BTD16-SG-401
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Health

Outcome Measures

Primary Outcomes (2)

• Composition of oral microbiome - reduction of microflora

  The change (amount and variety) of oral microflora species composition from baseline after the usage of a single dose of different antiseptic mouth washes using next generation sequencing (NGS) and real-time PCR techniques at 3 mins and 240 mins .

  Swab 1 - 0 Min, Swab 2 - 3 min (post treatment) and Swab 3 - 240 min (post treatment)

• Composition of oral microbiome - maintenance of healthy microflora

  The change (amount and variety) of healthy oral microflora species composition from baseline after the usage of a single dose of different antiseptic mouth washes using next generation sequencing (NGS) and real-time PCR techniques at 3 mins and 240 mins.

  Swab 1 - 0 Min, Swab 2 - 3 min (post treatment) and Swab 3 - 240 min (post treatment)

Study Arms (3)

Treatment Sequence Group 1

ACTIVE COMPARATOR

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).

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

Treatment Sequence Group 2

ACTIVE COMPARATOR

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

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

Treatment Sequence Group 3

ACTIVE COMPARATOR

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)

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

Interventions

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

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

Treatment Sequence Group 1; Treatment Sequence Group 2; Treatment Sequence Group 3

0.2% Chlor-Rinse™ Chlorhexidine based mouth wash DRUG

0.2% Chlor-Rinse™ Chlorhexidine based mouth wash

Treatment Sequence Group 1; Treatment Sequence Group 2; Treatment Sequence Group 3

Normal saline gargle DRUG

Normal saline gargle

Treatment Sequence Group 1; Treatment Sequence Group 2; Treatment Sequence Group 3

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mundipharma Manufacturing Pte Ltd.: lead
• Singapore Polytechnic (SP): collaborator

Study Sites (1)

National University of Singapore Hospital

Singapore, 119074, Singapore

Location

MeSH Terms

Interventions

Mouthwashes

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 12 healthy volunteers will be randomized into 3 arms with 3 different treatment sequences with 4 healthy volunteers in each arm.

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: May 5, 2017
• Study Start: May 5, 2017
• Primary Completion: May 19, 2017
• Study Completion: May 19, 2017
• Last Updated: June 6, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)