Relationship Between Oral Hygiene in Newborns and Candida Spp.

• Sponsor: Faculty Sao Leopoldo Mandic Campinas (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03873753
• Collaborator: (none)
• Enrollment: 276
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 44
• Patients Per Site Per Month: 6.3

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Primary Completion Date: Jul 31, 2020
• Anticipated Study Completion Date: Dec 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change from number of Candida spp CFU/mm3 [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 [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 [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 [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 [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 [At baseline as well as once a month until the eruption of the first tooth (up to 14 months)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 2 Days
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty Sao Leopoldo Mandic	Campinas	Sao Paulo	Brazil	13045755

Sponsors and Collaborators

• Faculty Sao Leopoldo Mandic Campinas

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jose Carlos P Imparato, PhD, Senior Lecturer, Clinical Professor, Faculty Sao Leopoldo Mandic Campinas
• ClinicalTrials.gov Identifier: NCT03873753
• Other Study ID Numbers: SLM 6
• First Posted: Mar 13, 2019
• Last Update Posted: Mar 13, 2019
• Last Verified: Mar 1, 2019

• 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, PhD, Senior Lecturer, Clinical Professor, Faculty Sao Leopoldo Mandic Campinas: Pediatric dentistry; Mouth, Edentulous
• Additional relevant MeSH terms: Candidiasis; Candidiasis, Oral

Study Results

No Results Posted as of Mar 13, 2019