Relationship Between Oral Hygiene in Newborns and Candida Spp.

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

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.

Study Overview

• Status: Unknown
• Conditions: Candidiasis, Oral
• Intervention / Treatment: Other: Cleaning; Other: No oral cleaning

• Study Type: Interventional
• Enrollment (Anticipated): 276
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Campinas, Sao Paulo, Brazil, 13045755
      • Recruiting
      • Faculty Sao Leopoldo Mandic
      • Contact: Jose Carlos P Imparato, PhD; Phone Number: +551935183601; Email: jimparato@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral cleaning; The oral cavity will be clean with gauze and mineral water three times a day.	Other: Cleaning; Gauze and mineral water
Active Comparator: No oral cleaning; The oral cavity will not be cleaned.	Other: No oral cleaning; Absence of cleaning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Faculty Sao Leopoldo Mandic Campinas
• Investigators: Principal Investigator: Jose Carlos P Imparato, PhD, Faculdade Sao Leopoldo Mandic, Campinas, SP, Brazil

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Pediatric dentistry; Mouth, Edentulous
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Mouth Diseases; Bacterial Infections and Mycoses; Mycoses; Candidiasis; Candidiasis, Oral
• Other Study ID Numbers: SLM 6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No