Oral HealthPhase 4NCT03141554
The Effect of Oral Antiseptic Gargles on the Oral Cavity Microbiome
A Phase 4 study testing 1% Betadine® PVP-I based mouth wash and gargle,, 0.2% Chlor-Rinse™ Chlorhexidine based mouth wash and Normal saline gargle in people with Oral Health, run by Mundipharma Manufacturing Pte Ltd. at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Health
- What is being tested?
- 1% Betadine® PVP-I based mouth wash and gargle,, 0.2% Chlor-Rinse™ Chlorhexidine based mouth wash and Normal saline gargle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSingapore
- Study dates
- 5 May 2017to 19 May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Oral Health
- Being tested
- 1% Betadine® PVP-I based mouth wash and gargle,, 0.2% Chlor-Rinse™ Chlorhexidine based mouth wash, Normal saline gargle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Betadine® PVP-I based mouth wash and gargle,Drug
1% Betadine® PVP-I based mouth wash and gargle
0.2% Chlor-Rinse™ Chlorhexidine based mouth washDrug
0.2% Chlor-Rinse™ Chlorhexidine based mouth wash
Normal saline gargleDrug
Normal saline gargle
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: 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) Receives: Drug: 1% Betadine® PVP-I based mouth wash and gargle,; Drug: 0.2% Chlor-Rinse™ Chlorhexidine based mouth wash; Drug: Normal saline gargle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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.
Measured: Swab 1 - 0 Min, Swab 2 - 3 min (post treatment) and Swab 3 - 240 min (post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start5 May 2017
- Primary completion19 May 2017
- Study completion19 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 12 healthy volunteers will be randomized into 3 arms with 3 different treatment sequences with 4 healthy volunteers in each arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Manufacturing Pte Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Singapore Polytechnic (SP)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141554
- Sponsor's protocol ID
- BTD16-SG-401
- Status last verified
- Jun 2017
- First submitted
- 22 Feb 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Antiseptic Gargles on the Oral Cavity Microbiome
- ClinicalTrials.gov ID
- NCT03141554
- Acronym / sponsor ID
- BTD16-SG-401
- Conditions
- Oral Health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mundipharma Manufacturing Pte Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Singapore Polytechnic (SP)
- Study start
- 5 May 2017 (actual)
- Primary completion
- 19 May 2017 (actual)
- Study completion
- 19 May 2017 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 12 healthy volunteers will be randomized into 3 arms with 3 different treatment sequences with 4 healthy volunteers in each arm.
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence Group 1 | Active comparator | Drug: 1% Betadine® PVP-I based mouth wash and gargle,, Drug: 0.2% Chlor-Rinse™ Chlorhexidine based mouth wash, Drug: Normal saline gargleTreatment 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 Sequence Group 2 | Active comparator | Drug: 1% Betadine® PVP-I based mouth wash and gargle,, Drug: 0.2% Chlor-Rinse™ Chlorhexidine based mouth wash, Drug: Normal saline gargleTreatment 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 Sequence Group 3 | Active comparator | Drug: 1% Betadine® PVP-I based mouth wash and gargle,, Drug: 0.2% Chlor-Rinse™ Chlorhexidine based mouth wash, Drug: Normal saline gargleTreatment 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) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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),
Key exclusion criteria (7 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1% Betadine® PVP-I based mouth wash and gargle,1% Betadine® PVP-I based mouth wash and gargle | Drug | Treatment Sequence Group 1, Treatment Sequence Group 2, Treatment Sequence Group 3 |
| 0.2% Chlor-Rinse™ Chlorhexidine based mouth wash0.2% Chlor-Rinse™ Chlorhexidine based mouth wash | Drug | Treatment Sequence Group 1, Treatment Sequence Group 2, Treatment Sequence Group 3 |
| Normal saline gargleNormal saline gargle | Drug | Treatment Sequence Group 1, Treatment Sequence Group 2, Treatment Sequence Group 3 |
Primary outcome
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 .
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1% Betadine® PVP-I based mouth wash and gargle,, 0.2% Chlor-Rinse™ Chlorhexidine based mouth wash and Normal saline gargle in people with Oral Health, run by Mundipharma Manufacturing Pte Ltd. at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.