Relationship Between Oral Hygiene in Newborns and Candida Spp.

Study Overview
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Brief Summary
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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.

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

Conditions
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Candidiasis, Oral

Intervention / Treatment
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* Other: Cleaning
* Other: No oral cleaning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 2 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric dentistry, Mouth, Edentulous