Relationship Between Oral Hygiene in Newborns and Candida Spp.

Not Applicable

• Conditions: Candidiasis, Oral
• Interventions: Other: Cleaning; Other: No oral cleaning

• Registration Number: NCT03873753
• Lead Sponsor: Faculty Sao Leopoldo Mandic Campinas

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-02
• Study First Submitted: 2019-02-21
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-12
• Last Update Submitted: 2019-03-12
• Study First Posted: 2019-03-13
• Last Update Posted: 2019-03-13
• Primary Completion: 2020-07-31
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 276

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral cleaning	Cleaning	The oral cavity will be clean with gauze and mineral water three times a day.
No oral cleaning	No oral cleaning	The oral cavity will not be cleaned.

Primary Outcome Measures

Name	Time	Method
Change from number of Candida spp CFU/mm3	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 Outcome Measures

Name	Time	Method
Mean of patient's gestational week in the test group as assessed by questionnaire	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	At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Mean of patient's birth weight in the test group as assessed by questionnaire	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	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	At baseline as well as once a month until the eruption of the first tooth (up to 14 months)

Trial Locations

Locations (1)

Faculty Sao Leopoldo Mandic; 🇧🇷 Campinas, Sao Paulo, Brazil