NCT03873753

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

3.2 years

First QC Date

February 21, 2019

Last Update Submit

March 12, 2019

Conditions

Candidiasis, Oral

Keywords

Pediatric dentistryMouth, Edentulous

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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)

  • 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 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)

  • 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)

Study Arms (2)

Oral cleaning

EXPERIMENTAL

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

Other: Cleaning

No oral cleaning

ACTIVE COMPARATOR

The oral cavity will not be cleaned.

Other: No oral cleaning

Interventions

CleaningOTHER

Gauze and mineral water

Oral cleaning
No oral cleaningOTHER

Absence of cleaning

No oral cleaning

Eligibility Criteria

AgeUp to 2 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • A signed statement of informed consent
  • Newborns up to 48 hours of life
  • Exclusive breastfeeding
  • Edentulous oral cavity

You may not qualify if:

  • Any feeding other than breastfeeding
  • Use of pacifier
  • Digit sucking
  • Systemic alterations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty Sao Leopoldo Mandic

Campinas, São Paulo, 13045755, Brazil

RECRUITING

MeSH Terms

Conditions

Candidiasis, OralMouth, Edentulous

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsMouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Jose Carlos P Imparato, PhD

    Faculdade Sao Leopoldo Mandic, Campinas, SP, Brazil

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Regina E. da Silva, PhD

CONTACT

+55 11 945179999secheverria@uol.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Senior Lecturer, Clinical Professor

Study Record Dates

First Submitted

February 21, 2019

First Posted

March 13, 2019

Study Start

May 2, 2017

Primary Completion

July 31, 2020

Study Completion

December 30, 2020

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations

BR(1)