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Effect of Oral Hygienization in Newborn on Candida Spp Colonization

NCT04410250 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2020-06-01

No results posted yet for this study

Summary

Oral hygiene is one of the most accessible and well-known strategies for the prevention of dental caries. The benefits of this practice after tooth eruption are well established in the literature. Oral hygiene in newborns prior to tooth eruption is controversial, since there is a disagreement between the Dental and Pediatric Associations as to the optimal time to initiate oral hygiene in children and scientific studies in this regard have not yet been performed. Some of these associations recommend starting this practice from the eruption of the child's first tooth. Others recommend beginning the cleansing of the child's oral cavity from birth by cleaning the baby's gingival rollers and tongue. The aim of the present investigation will be to evaluate, through a randomized clinical trial, the influence of oral hygiene in newborns on Candida spp colonization. and on the child's behavior during oral hygiene after tooth eruption. Will be included in the study, pairs of mothers and babies born in the maternity of the Hospital Nossa Senhora da Saúde, in Diamantina, Minas Gerais, Brazil.

This will be a rehearsal Randomized clinical trial in which newborns will be allocated into 2 groups, namely:

* Newborns whose parents will receive guidelines for oral hygiene before tooth eruption (Group 1);
* Newborns whose parents will receive instructions not to perform oral hygiene before tooth eruption (Group 2).

The initial data collection will be performed one month after the child's birth and will include oral clinical examinations, saliva collection and questionnaires on the socio-environmental, economic and behavioral aspects of the child and his family. Initial oral clinical examinations will be performed to assess the presence of Candidiasis, and saliva collection will be performed to identify and quantification of Candida spp. These evaluations will be performed again every three months. From the eruption of the first deciduous tooth, the follow-up included an assessment of the baby's behavior during oral hygiene performed by the responsible. This evaluation will be made by the examiner using the Frankl scale and HBCD scale criteria. Statistical analysis will be performed using the Statistical Package for Social Science, version 23.0 and will include descriptive, bivariate and multivariate analyzes.

Conditions

  • Newborns
  • Oral Hygiene
  • Candidiasis, Oral
  • Behavior

Interventions

BEHAVIORAL

oral hygiene

Mothers will be instructed on the oral hygiene of the newborn

Sponsors & Collaborators

  • Federal University of the Valleys of Jequitinhonha and Mucuri

    lead OTHER

Principal Investigators

  • Ana Beatriz S Lopes, Graduated · Federal University of the Valleys of Jequitinhonha and Mucuri

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
2 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2020-08-06
Completion
2020-12-10

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04410250 on ClinicalTrials.gov