Relationship Between Oral Hygiene in Newborns and Candida Spp.

Faculty Sao Leopoldo Mandic Campinas

Status: Unknown

Conditions: Candidiasis, Oral

Treatments: Other: No oral cleaning; Other: Cleaning

Study type: Interventional

Funder types: Other

Identifiers

NCT03873753

SLM 6

Details and patient eligibility

About

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.

Enrollment: 276 estimated patients

Sex: All

Ages: Under 2 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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276 participants in 2 patient groups

Oral cleaning

Experimental group

Description:

The oral cavity will be clean with gauze and mineral water three times a day.

Treatment:

Other: Cleaning

No oral cleaning

Active Comparator group

Description:

The oral cavity will not be cleaned.

Treatment:

Other: No oral cleaning