The Effect of Oral Antiseptic Gargles on the Oral Cavity Microbiome

June 5, 2017 updated by: Mundipharma Manufacturing Pte Ltd.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 119074
        • National University of Singapore Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Treatment Sequence Group 1

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,
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
Active Comparator: Treatment Sequence Group 2

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,
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
Active Comparator: Treatment Sequence Group 3

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,
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composition of oral microbiome - reduction of microflora
Time Frame: Swab 1 - 0 Min, Swab 2 - 3 min (post treatment) and Swab 3 - 240 min (post treatment)
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
Time Frame: Swab 1 - 0 Min, Swab 2 - 3 min (post treatment) and Swab 3 - 240 min (post treatment)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mundipharma Manufacturing Pte Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Singapore Polytechnic (SP)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 19, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BTD16-SG-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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