Relationship Between Oral Hygiene in Newborns and Candida Spp.

Candidiasis, Oral Clinical Trial

Official title:

Relationship Between Oral Hygiene in Newborns and Candida Spp.: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03873753
• Other study ID #: SLM 6
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2019
• Source: Faculty Sao Leopoldo Mandic Campinas
• Contact: Sandra Regina E. da Silva, PhD
• Phone: +55 11 945179999
• Email: secheverria[@]uol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 276
• Est. completion date: December 30, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 2 Days

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Oral

Intervention

Other:
• Cleaning
Gauze and mineral water
• No oral cleaning
Absence of cleaning

Locations

Country	Name	City	State
Brazil	Faculty Sao Leopoldo Mandic	Campinas	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Faculty Sao Leopoldo Mandic Campinas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)