Dental CariesPhase 1NCT04550546
Effects of Nystatin Suspension Oral Application on Oral Microbial Community
A Phase 1 study testing Nystatin in people with Dental Caries, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of a prescription mouth rinse (Nystatin),an FDA approved drug, on the different types of bacteria in the mouth. Results from this study may help understand the effect that Nystatin oral rinse has on certain types of oral bacteria, which may also cause tooth decay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Caries
- What is being tested?
- Nystatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2021to 28 Feb 2022
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to participate in this study and able to come for follow-up appointments.
- Has positive oral Candida detection and the amount of oral Candida meet the laboratory criteria for diagnosing oral Candidiasis (>= 400 colony forming unit in saliva).
- Has ≥ 10,000 CFU/mL of S. mutans in the saliva (justification: individuals with ≥ 10,000 CFU/mL salivary S. mutans are considered at elevated risk for dental caries).
- Ability to consent, comply with all study procedures and be available for the duration of the study.
Who cannot join
- visible signs of candidiasis on the mucosa or tongue at screening (Patients will be referred for treatment immediately)
- Patient with systemic diseases, such as HIV, cancer or diabetes. This will be answered by study participants and further confirmed by using electronic medical record (EPIC) for those participants who have records in the EPIC system. (Justification: patient with systemic diseases is that patients with these conditions are more prone to yeast and bacterial infection)
- History of local (oral) or systemic antibiotics or antifungal medication within the last 3 months. This will be answered by study participants and further confirmed by using electronic medical record (EPIC) for those participants who have records in the EPIC system.
- Women who are currently pregnant or reported that she is currently breast feeding . A pregnancy test (urine test) will be conducted to exclude participants who are pregnant. Rational of excluding pregnant women and women are currently breastfeeding their children: Nystatin oral suspension is classified as FDA pregnancy risk category C. It's also unknown whether nystatin is excreted in human milk.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the effect of a prescription mouth rinse (Nystatin),an FDA approved drug, on the different types of bacteria in the mouth. Results from this study may help understand the effect that Nystatin oral rinse has on certain types of oral bacteria, which may also cause tooth decay.
Read the detailed description
This is a prospective, single-arm clinical trial of patients diagnosed with oral candidiasis.
designed clinical study. All study participants will have positive oral Candida detection with sufficient oral Candida burden to meet the laboratory criteria for a diagnosis of oral candidiasis (≥ 400 CFU/mL of salivary Candida, a standard that was established by Dr. Epstein at the Department of Oral Diagnosis and Department of Microbiology and Immunology at the University of Washington in 1980). All study participants will receive treatment for oral candidiasis using nystatin suspension (Brand name: Mycostatin), and be instructed to rinse the mouth with (6ml of 600,000 U/mL) nystatin suspension, followed by spitting out the suspension, at the frequency of four times per day, for a period of 1 week. The oral microbial changes including fungal and cariogenic bacteria (e.g. S. mutans) will be monitored immediately (within 7 days) and 3-months following the completion of the 1-week Nystatin application. Detailed inclusion and exclusion criteria and methods see below.
- Conditions
- Dental Caries
- Being tested
- Nystatin
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NystatinDrug
600,000 U/mL of nystatin in a rinse suspension
| Study group | Role | What they receive |
|---|---|---|
| Nystatin treatment | Experimental | Participants will be given 1-week supply of nystatin suspension (6ml 600,000 U/mL) and be instructed to rinse the mouth with nystatin for 1 minute and spit out the suspension, at a frequency of four times a day, for a duration of 1 week. Participants will be instructed to spit the suspension after the oral rinse and do not swallow the suspension, and they will be instructed to avoid eating, drinking and brushing their teeth for 30 minutes. Receives: Drug: Nystatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in S. Mutans carriage
Subjects' whole non-stimulated saliva samples will be collected by spitting into a sterilized 50ml centrifuge tube. S. mutans will be isolated using Mitis Salivarius with Bacitracin selective medium (37°C for 48h) and identified by colony morphology. S. mutans carriage following nystatin suspension oral application using the colony forming unit and scoring (1: no detection, 2: 1-10,000 CFU/mL; 3: >10,000 CFU/mL). Higher scores indicate worse outcome.
Measured: baseline to 3 months
Secondary outcomes (5)
Mean C Albicans carriage
Subjects' whole non-stimulated saliva samples will be collected by spitting into a sterilized 50ml centrifuge tube. BBLTM CHROMagarTM Candida (BD, Sparks, MD, USA) will be used to isolate C. albicans (37°C for 48h). This medium permits presumptive identification of several clinically important Candida species including C. albicans based on colony color and morphology. C. albicans detection and carriage following nystatin suspension oral application using colony forming unit and scoring (1: no detection, 2: 1-400 CFU/mL; 3: >400 CFU/mL).
Measured: baseline to 3 months
Mean change in plaque index
Dental plaque status will be assessed using the Plaque Index. Each of the four gingival areas of the tooth will be given a score from 0-3. A score of 0 indicates no plaque in the gingival area, a score of 1 indicates the presence of a film of plaque adhering to the free gingival margin, a score of 2 indicates moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and or adjacent tooth, a score of 3 indicates abundance of soft matter within the gingival pocket and or on the gingival margin and adjacent tooth structure. The scores of each tooth surface will be added and divided by the number of teeth examined to obtain the plaque index score. Higher scores indicate worse outcome
Measured: baseline to 3 months
Mean change in number of bleeding on probing sites
Bleeding on probing (BOP) will be evaluated to reflect the periodontal status. With a periodontal probe, the periodontal tissue will be assessed to the bottom of the clinical pocket or sulcus. No extra effort will be made to apply a pressure. If bleeding occurs within 10-15 seconds after probing, the positive mark will be recorded on the form. Interproximal sites for every existing tooth, except the third molars, will be scored both from the buccal and the lingual sides. Due to the different numbers of existing teeth for each subject, the change in numbers of BOP sites will be measured and compared.
Measured: baseline to 3 months
Mean change in diversity as measured by the Shannon Index
We will use established methods to perform the oral microbiome sequencing and related bioinformatics analysis. Genomic DNA from clinical samples will be extracted. The bacterial 16S rRNA V1-V3 hypervariable region and fungal ITS region will be amplified and sequenced on an Illumina MiSeq. Absolute abundance of bacteria and fungi in each sample will be determined by quantitative real-time PCR using 16s and ITS primers, probe and cloned plasmid standards. Sequence reads will be assessed for quality using Quantitative Insights into Microbial Ecology software. USearch will be used to identify specific bacteria/fungi or operational taxonomic units using the GreenGenes and UNITE databases of reference sequences. Bacterial diversity within each sample (alpha diversity) will be computed as the Shannon Index. Equitability assumes a value between 0 and 1 with 1 being complete evenness.
Measured: baseline to 3 months
Mean change in diversity as measured by the Bray-Curtis dissimilarity index
We will use established methods to perform the oral microbiome sequencing and related bioinformatics analysis. Genomic DNA from clinical samples will be extracted. The bacterial 16S rRNA V1-V3 hypervariable region and fungal ITS region will be amplified and sequenced on an Illumina MiSeq. Absolute abundance of bacteria and fungi in each sample will be determined by quantitative real-time PCR using 16s and ITS primers, probe and cloned plasmid standards. Sequence reads will be assessed for quality using Quantitative Insights into Microbial Ecology software. USearch will be used to identify specific bacteria/fungi or operational taxonomic units using the GreenGenes and UNITE databases of reference sequences. Bacterial diversity between samples (beta diversity) will be computed as the Bray-Curtis dissimilarity index. The Bray-Curtis dissimilarity is a number between 0 (the two sites share all the same species) and 1 (they do not share any species).
Measured: baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start15 May 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Xiao, University of Rochester
- Investigators
- Jin Xiao, DDS, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550546
- Sponsor's protocol ID
- STUDY00004638
- Status last verified
- Jun 2022
- First submitted
- 9 Sep 2020
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nystatin Suspension Oral Application on Oral Microbial Community
- ClinicalTrials.gov ID
- NCT04550546
- Acronym / sponsor ID
- STUDY00004638
- Conditions
- Dental Caries
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 16 Sep 2020 (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.
The purpose of this study is to examine the effect of a prescription mouth rinse (Nystatin),an FDA approved drug, on the different types of bacteria in the mouth. Results from this study may help understand the effect that Nystatin oral rinse has on certain types of oral bacteria, which may also cause tooth decay.
Detailed description
This is a prospective, single-arm clinical trial of patients diagnosed with oral candidiasis.
designed clinical study. All study participants will have positive oral Candida detection with sufficient oral Candida burden to meet the laboratory criteria for a diagnosis of oral candidiasis (≥ 400 CFU/mL of salivary Candida, a standard that was established by Dr. Epstein at the Department of Oral Diagnosis and Department of Microbiology and Immunology at the University of Washington in 1980). All study participants will receive treatment for oral candidiasis using nystatin suspension (Brand name: Mycostatin), and be instructed to rinse the mouth with (6ml of 600,000 U/mL) nystatin suspension, followed by spitting out the suspension, at the frequency of four times per day, for a period of 1 week. The oral microbial changes including fungal and cariogenic bacteria (e.g. S. mutans) will be monitored immediately (within 7 days) and 3-months following the completion of the 1-week Nystatin application. Detailed inclusion and exclusion criteria and methods see below.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nystatin treatment | Experimental | Drug: NystatinParticipants will be given 1-week supply of nystatin suspension (6ml 600,000 U/mL) and be instructed to rinse the mouth with nystatin for 1 minute and spit out the suspension, at a frequency of four times a day, for a duration of 1 week. Participants will be instructed to spit the suspension after the oral rinse and do not swallow the suspension, and they will be instructed to avoid eating, drinking and brushing their teeth for 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing to participate in this study and able to come for follow-up appointments.
- Has positive oral Candida detection and the amount of oral Candida meet the laboratory criteria for diagnosing oral Candidiasis (>= 400 colony forming unit in saliva).
- Has ≥ 10,000 CFU/mL of S. mutans in the saliva (justification: individuals with ≥ 10,000 CFU/mL salivary S. mutans are considered at elevated risk for dental caries).
- Ability to consent, comply with all study procedures and be available for the duration of the study.
Key exclusion criteria (4 listed)
- visible signs of candidiasis on the mucosa or tongue at screening (Patients will be referred for treatment immediately)
- Patient with systemic diseases, such as HIV, cancer or diabetes. This will be answered by study participants and further confirmed by using electronic medical record (EPIC) for those participants who have records in the EPIC system. (Justification: patient with systemic diseases is that patients with these conditions are more prone to yeast and bacterial infection)
- History of local (oral) or systemic antibiotics or antifungal medication within the last 3 months. This will be answered by study participants and further confirmed by using electronic medical record (EPIC) for those participants who have records in the EPIC system.
- Women who are currently pregnant or reported that she is currently breast feeding . A pregnancy test (urine test) will be conducted to exclude participants who are pregnant. Rational of excluding pregnant women and women are currently breastfeeding their children: Nystatin oral suspension is classified as FDA pregnancy risk category C. It's also unknown whether nystatin is excreted in human milk.
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 |
|---|---|---|
| Nystatin600,000 U/mL of nystatin in a rinse suspension | Drug | Nystatin treatment |
Primary outcome
Mean change in S. Mutans carriage
Time frame: baseline to 3 months
Subjects' whole non-stimulated saliva samples will be collected by spitting into a sterilized 50ml centrifuge tube. S. mutans will be isolated using Mitis Salivarius with Bacitracin selective medium (37°C for 48h) and identified by colony morphology. S. mutans carriage following nystatin suspension oral application using the colony forming unit and scoring (1: no detection, 2: 1-10,000 CFU/mL; 3: >10,000 CFU/mL). Higher scores indicate worse outcome.
5 secondary outcomes
Mean C Albicans carriage
Time frame: baseline to 3 months
Mean change in plaque index
Time frame: baseline to 3 months
Mean change in number of bleeding on probing sites
Time frame: baseline to 3 months
Mean change in diversity as measured by the Shannon Index
Time frame: baseline to 3 months
Mean change in diversity as measured by the Bray-Curtis dissimilarity index
Time frame: baseline to 3 months
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 15 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
Jin Xiao, DDS, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nystatin in people with Dental Caries, run by University of Rochester at 1 site in United States.
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 4 inclusion and 4 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 15 Jun 2022. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Mean change in S. Mutans carriage (time frame: baseline to 3 months). 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 15 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.