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Relationship Between Oral Hygiene in Newborns and Candida Spp.

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ClinicalTrials.gov Identifier: NCT03873753
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Jose Carlos P Imparato, Faculty Sao Leopoldo Mandic Campinas

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.

Condition or disease Intervention/treatment Phase
Candidiasis, Oral Other: Cleaning Other: No oral cleaning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Relationship Between Oral Hygiene in Newborns and Candida Spp.: A Randomized Clinical Trial
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

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




Primary Outcome Measures :
  1. Change from number of Candida spp CFU/mm3 [ Time Frame: At 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 Outcome Measures :
  1. Mean of patient's birth weight in the test group as assessed by questionnaire [ Time Frame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months) ]
  2. Number of males in the test group as assessed by questionnaire [ Time Frame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months) ]
  3. Number of cesarean delivery in the test group as assessed by questionnaire [ Time Frame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months) ]
  4. Mean of patient's gestational week in the test group as assessed by questionnaire [ Time Frame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months) ]
  5. Mean of patient's birth length in the test group as assessed by questionnaire [ Time Frame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months) ]


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Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873753


Contacts
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Contact: Sandra Regina E. da Silva, PhD +55 11 945179999 secheverria@uol.com.br

Locations
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Brazil
Faculty Sao Leopoldo Mandic Recruiting
Campinas, Sao Paulo, Brazil, 13045755
Contact: Jose Carlos P Imparato, PhD    +551935183601    jimparato@usp.br   
Sponsors and Collaborators
Faculty Sao Leopoldo Mandic Campinas
Investigators
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Principal Investigator: Jose Carlos P Imparato, PhD Faculdade Sao Leopoldo Mandic, Campinas, SP, Brazil

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Responsible Party: Jose Carlos P Imparato, PhD, Senior Lecturer, Clinical Professor, Faculty Sao Leopoldo Mandic Campinas
ClinicalTrials.gov Identifier: NCT03873753     History of Changes
Other Study ID Numbers: SLM 6
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jose Carlos P Imparato, Faculty Sao Leopoldo Mandic Campinas:
Pediatric dentistry
Mouth, Edentulous
Additional relevant MeSH terms:
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Candidiasis
Candidiasis, Oral
Mycoses
Mouth Diseases
Stomatognathic Diseases