Effect of Oral Hygienization in Newborn on Candida Spp Colonization

NCT04410250 | Unknown

• 1 other identifier: 3.568.480
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Neonate.; Newborn.; Oral hygiene.; Oral health.; Candidiasis.

Outcome Measures

Primary Outcomes (2)

• Colonization of Candida spp.

  In the first month after the birth of the child, an initial oral clinical examination and saliva collection will be performed to evaluate Candida spp colonization. These two assessments will be performed at the child's own home.

  First month after the birth of the child

• Colonization of Candida spp.

  Four months after the birth of the child, an initial oral clinical examination and saliva collection will be performed to evaluate Candida spp colonization. These two assessments will be performed at the child's own home.

  Four months after the birth of the child

Secondary Outcomes (6)

• Baby Behavior During Oral Hygiene

  Seven months after the birth of the child

• Baby Behavior During Oral Hygiene

  Seven months after the birth of the child

• Baby Behavior During Oral Hygiene

  Ten months after the birth of the child

• Baby Behavior During Oral Hygiene

  Ten months after the birth of the child

• Baby Behavior During Oral Hygiene

  Thirteen months after the birth of the child

Study Arms (2)

Oral hygiene before tooth eruption

ACTIVE COMPARATOR

The mothers of the newborns allocated to Group 1 will be instructed to clean the child's oral cavity by massaging the gingival rods with gauze and filtered water once a day at night. Following the eruption of the child's first tooth, mothers will be instructed to brush twice a day with fluoride toothpaste (1100 ppm fluoride) in a minimum amount, equivalent to one grain of raw rice, using the Fones technique. circular movements in the buccal and lingual faces of all teeth (FONES, 1934).

Behavioral: oral hygiene

Absence of oral hygiene before tooth eruption

EXPERIMENTAL

The mothers of the newborns allocated to Group 2 will be advised not to perform any type of oral cavity cleaning of the newborn. Following the eruption of the child's first tooth, mothers will be instructed to brush twice a day with fluoride toothpaste (1100 ppm fluoride) in a minimum amount, equivalent to one grain of raw rice, using the Fones technique. circular movements in the buccal and lingual faces of all teeth (FONES, 1934).

Behavioral: oral hygiene

Interventions

oral hygiene BEHAVIORAL

Mothers will be instructed on the oral hygiene of the newborn

Absence of oral hygiene before tooth eruption; Oral hygiene before tooth eruption

Eligibility Criteria

• Age: 1 Day - 2 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborns who do not yet have erupted teeth at the time of the first assessment (1 month after birth).
• Newborns whose mothers agree with their participation and that of their child in the study.

You may not qualify if:

• Newborns who present with systemic impairment at the time of the first evaluation (1 month after birth), such as physical, neurological, respiratory diseases, gastroesophageal reflux disease, among others that may alter the oral microbiota.

Sponsors & Collaborators

• Federal University of the Valleys of Jequitinhonha and Mucuri: lead

Study Sites (1)

Ana Beatriz Silva Lopes

Diamantina, Minas Gerais, 39100.000, Brazil

RECRUITING

MeSH Terms

Conditions

Candidiasis, Oral; Behavior; Candidiasis

Interventions

Oral Hygiene

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hygiene; Therapeutics; Preventive Dentistry; Dentistry

Study Officials

• Ana Beatriz S Lopes, Graduated

  Federal University of the Valleys of Jequitinhonha and Mucuri

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Beatriz S Lopes, Graduated

CONTACT

(38)9 9749-3916; anabeatriz.lopes@hotmail.com.br

Marcos L Pinheiro, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blindness The interventions will always be made by the same researcher and will not participate in the evaluations. Examiner 1 will be blinded to the group in which the examined children were allocated. Mothers will be advised not to disclose the group in which they were allocated during the evaluations.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sample Size in Brazil: 102 Groups into which survey participants will be divided at this center: Group 1: 51 (Newborns whose parents will receive oral hygiene guidelines prior to tooth eruption) Group 2: 51 ( Newborns whose parents will be advised not to perform oral hygiene prior to tooth eruption.)

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: June 1, 2020
• Study Start: November 1, 2019
• Primary Completion: August 6, 2020
• Study Completion: December 10, 2020
• Last Updated: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)