Relationship Between Oral Hygiene in Newborns and Candida Spp.
Overview
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.
Full Title of Study: “Relationship Between Oral Hygiene in Newborns and Candida Spp.: A Randomized Clinical Trial”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Single (Investigator)
- Study Primary Completion Date: July 31, 2020
Interventions
- Other: Cleaning
- Gauze and mineral water
- Other: No oral cleaning
- Absence of cleaning
Arms, Groups and Cohorts
- Experimental: Oral cleaning
- The oral cavity will be clean with gauze and mineral water three times a day.
- Active Comparator: No oral cleaning
- The oral cavity will not be cleaned.
Clinical Trial Outcome Measures
Primary Measures
- 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)
Secondary Measures
- 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)
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: 2 Days
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Faculty Sao Leopoldo Mandic Campinas
- Provider of Information About this Clinical Study
- Principal Investigator: Jose Carlos P Imparato, PhD, Senior Lecturer, Clinical Professor – Faculty Sao Leopoldo Mandic Campinas
- Overall Official(s)
- Jose Carlos P Imparato, PhD, Principal Investigator, Faculdade Sao Leopoldo Mandic, Campinas, SP, Brazil
- Overall Contact(s)
- Sandra Regina E. da Silva, PhD, +55 11 945179999, secheverria@uol.com.br
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