Skip to content

Relationship Between Oral Hygiene in Newborns and Candida Spp.

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03873753
Enrollment
276
Registered
2019-03-13
Start date
2017-05-02
Completion date
2020-12-30
Last updated
2019-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candidiasis, Oral

Keywords

Pediatric dentistry, Mouth, Edentulous

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.

Interventions

OTHERCleaning

Gauze and mineral water

OTHERNo oral cleaning

Absence of cleaning

Sponsors

Faculty Sao Leopoldo Mandic Campinas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from number of Candida spp CFU/mm3At 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

MeasureTime frame
Mean of patient's birth weight in the test group as assessed by questionnaireAt 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 questionnaireAt 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 questionnaireAt 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 questionnaireAt 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 questionnaireAt baseline as well as once a month until the eruption of the first tooth (up to 14 months)

Countries

Brazil

Contacts

Primary ContactSandra Regina E. da Silva, PhD
secheverria@uol.com.br+55 11 945179999

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026