Candidiasis, OralNCT03873753
Relationship Between Oral Hygiene in Newborns and Candida Spp.
A study testing Cleaning and No oral cleaning in people with Candidiasis, Oral, run by Faculty Sao Leopoldo Mandic Campinas at 1 site in Brazil.
Trial summary
Little is known regarding the effectiveness of neonatal oral hygiene and its relationship to colonization by Candida spp. in edentulous oral cavities. Thus, the objective of this study is to evaluate whether the oral hygiene of edentulous infants favors colonization by Candida spp. Read more about this study
- Who is it for?
- Ages Up to 2 daysHealthy volunteers can take part
- Conditions the study is for
- Candidiasis, Oral
- What is being tested?
- Cleaning and No oral cleaning
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteBrazil
- Study dates
- 2 May 2017to 30 Dec 2020
- Phase
- Interventional
- 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 Up to 2 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A signed statement of informed consent
- Newborns up to 48 hours of life
- Exclusive breastfeeding
- Edentulous oral cavity
Who cannot join
- Any feeding other than breastfeeding
- Use of pacifier
- Digit sucking
- Systemic alterations
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Faculty Sao Leopoldo Mandic
Campinas, São Paulo, 13045755
Jose Carlos P Imparato, PhD, +551935183601, jimparato@usp.br
About this study
Official title: Relationship Between Oral Hygiene in Newborns and Candida Spp.: A Randomized Clinical Trial
Little is known regarding the effectiveness of neonatal oral hygiene and its relationship to colonization by Candida spp. in edentulous oral cavities. Thus, the objective of this study is to evaluate whether the oral hygiene of edentulous infants favors colonization by Candida spp. Newborns with up to 48 hours of life will randomly allocated to two groups. The mothers will instructed to clean the oral cavity with gauze and mineral water three times a day, in the test group, and not to clean, in the control group.
- Conditions
- Candidiasis, Oral
- Being tested
- Cleaning, No oral cleaning
- Keywords
- Pediatric dentistry, Mouth, Edentulous
- Medical subject headings
- Candidiasis, Oral, Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CleaningOther
Gauze and mineral water
No oral cleaningOther
Absence of cleaning
| Study group | Role | What they receive |
|---|---|---|
| Oral cleaning | Experimental | The oral cavity will be clean with gauze and mineral water three times a day. Receives: Other: Cleaning |
| No oral cleaning | Active comparator | The oral cavity will not be cleaned. Receives: Other: No oral cleaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from number of Candida spp CFU/mm3
Non-stimulated saliva will be collected with the aid of a sterile swab (Absorve®) from all infants. The samples were incubated at 37°C and analyzed after 48 hours to quantify the colony forming units (CFU/mm3)
Measured: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Secondary outcomes (5)
Mean of patient's birth weight in the test group as assessed by questionnaire
Measured: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Number of males in the test group as assessed by questionnaire
Measured: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Number of cesarean delivery in the test group as assessed by questionnaire
Measured: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Mean of patient's gestational week in the test group as assessed by questionnaire
Measured: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Mean of patient's birth length in the test group as assessed by questionnaire
Measured: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start2 May 2017
- Primary completion31 Jul 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candidiasis, OralStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty Sao Leopoldo Mandic Campinas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Carlos P Imparato, Faculty Sao Leopoldo Mandic Campinas
- Investigators
- Jose Carlos P Imparato, PhD, Principal investigator, Faculdade Sao Leopoldo Mandic, Campinas, SP, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873753
- Sponsor's protocol ID
- SLM 6
- Status last verified
- Mar 2019
- First submitted
- 21 Feb 2019
- Last updated
- 13 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Oral Hygiene in Newborns and Candida Spp.: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03873753
- Acronym / sponsor ID
- SLM 6
- Conditions
- Candidiasis, Oral
- Keywords
- Pediatric dentistry, Mouth, Edentulous
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Faculty Sao Leopoldo Mandic CampinasUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 13 Mar 2019 (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.
Little is known regarding the effectiveness of neonatal oral hygiene and its relationship to colonization by Candida spp. in edentulous oral cavities. Thus, the objective of this study is to evaluate whether the oral hygiene of edentulous infants favors colonization by Candida spp. Newborns with up to 48 hours of life will randomly allocated to two groups. The mothers will instructed to clean the oral cavity with gauze and mineral water three times a day, in the test group, and not to clean, in the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral cleaning | Experimental | Other: CleaningThe oral cavity will be clean with gauze and mineral water three times a day. |
| No oral cleaning | Active comparator | Other: No oral cleaningThe oral cavity will not be cleaned. |
Who may qualify
- Ages
- Up to 2 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- A signed statement of informed consent
- Newborns up to 48 hours of life
- Exclusive breastfeeding
- Edentulous oral cavity
Key exclusion criteria (4 listed)
- Any feeding other than breastfeeding
- Use of pacifier
- Digit sucking
- Systemic alterations
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 |
|---|---|---|
| CleaningGauze and mineral water | Other | Oral cleaning |
| No oral cleaningAbsence of cleaning | Other | No oral cleaning |
Primary outcome
Change from number of Candida spp CFU/mm3
Time frame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Non-stimulated saliva will be collected with the aid of a sterile swab (Absorve®) from all infants. The samples were incubated at 37°C and analyzed after 48 hours to quantify the colony forming units (CFU/mm3)
5 secondary outcomes
Mean of patient's birth weight in the test group as assessed by questionnaire
Time frame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Number of males in the test group as assessed by questionnaire
Time frame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Number of cesarean delivery in the test group as assessed by questionnaire
Time frame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Mean of patient's gestational week in the test group as assessed by questionnaire
Time frame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Mean of patient's birth length in the test group as assessed by questionnaire
Time frame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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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.
Jose Carlos P Imparato, PhD principal investigator
Faculdade Sao Leopoldo Mandic, Campinas, SP, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cleaning and No oral cleaning in people with Candidiasis, Oral, run by Faculty Sao Leopoldo Mandic Campinas at 1 site in Brazil.
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: status not confirmed, as of the sponsor's last update on 13 Mar 2019. 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 Brazil. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra Regina E. da Silva, PhD (+55 11 945179999, secheverria@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from number of Candida spp CFU/mm3 (time frame: At baseline as well as once a month until the eruption of the first tooth (up to 14 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 13 Mar 2019.