Relationship Between Oral Hygiene in Newborns and Candida Spp.
Primary Purpose
Candidiasis, Oral
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cleaning
No oral cleaning
Sponsored by
About this trial
This is an interventional prevention trial for Candidiasis, Oral focused on measuring Pediatric dentistry, Mouth, Edentulous
Eligibility Criteria
Inclusion Criteria:
- A signed statement of informed consent
- Newborns up to 48 hours of life
- Exclusive breastfeeding
- Edentulous oral cavity
Exclusion Criteria:
- Any feeding other than breastfeeding
- Use of pacifier
- Digit sucking
- Systemic alterations
Sites / Locations
- Faculty Sao Leopoldo MandicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Oral cleaning
No oral cleaning
Arm Description
The oral cavity will be clean with gauze and mineral water three times a day.
The oral cavity will not be cleaned.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Mean of patient's birth weight in the test group as assessed by questionnaire
Number of males in the test group as assessed by questionnaire
Number of cesarean delivery in the test group as assessed by questionnaire
Mean of patient's gestational week in the test group as assessed by questionnaire
Mean of patient's birth length in the test group as assessed by questionnaire
Full Information
NCT ID
NCT03873753
First Posted
February 21, 2019
Last Updated
March 12, 2019
Sponsor
Faculty Sao Leopoldo Mandic Campinas
1. Study Identification
Unique Protocol Identification Number
NCT03873753
Brief Title
Relationship Between Oral Hygiene in Newborns and Candida Spp.
Official Title
Relationship Between Oral Hygiene in Newborns and Candida Spp.: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty Sao Leopoldo Mandic Campinas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Oral
Keywords
Pediatric dentistry, Mouth, Edentulous
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
276 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oral cleaning
Arm Type
Experimental
Arm Description
The oral cavity will be clean with gauze and mineral water three times a day.
Arm Title
No oral cleaning
Arm Type
Active Comparator
Arm Description
The oral cavity will not be cleaned.
Intervention Type
Other
Intervention Name(s)
Cleaning
Intervention Description
Gauze and mineral water
Intervention Type
Other
Intervention Name(s)
No oral cleaning
Intervention Description
Absence of cleaning
Primary Outcome Measure Information:
Title
Change from number of Candida spp CFU/mm3
Description
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)
Time Frame
At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
2 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A signed statement of informed consent
Newborns up to 48 hours of life
Exclusive breastfeeding
Edentulous oral cavity
Exclusion Criteria:
Any feeding other than breastfeeding
Use of pacifier
Digit sucking
Systemic alterations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Regina E. da Silva, PhD
Phone
+55 11 945179999
Email
secheverria@uol.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Carlos P Imparato, PhD
Organizational Affiliation
Faculdade Sao Leopoldo Mandic, Campinas, SP, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty Sao Leopoldo Mandic
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13045755
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Carlos P Imparato, PhD
Phone
+551935183601
Email
jimparato@usp.br
12. IPD Sharing Statement
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Relationship Between Oral Hygiene in Newborns and Candida Spp.
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