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Chronic Malnutrition and Oral Health Status in Children Aged One to Five Years

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ClinicalTrials.gov Identifier: NCT03529500
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sandra Kalil Bussadori, University of Nove de Julho

Tracking Information
First Submitted Date April 15, 2018
First Posted Date May 18, 2018
Last Update Posted Date May 18, 2018
Actual Study Start Date February 2, 2017
Actual Primary Completion Date April 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2018)
  • Weight Measurement [ Time Frame: 4 weeks ]
    The children were weighed on a previously calibrated electronic scale (capacity: 150 kg; precision: 100 g) barefoot and wearing light clothing in the presence of the mother or caregiver.
  • Height Measurement [ Time Frame: 4 weeks ]
    Height was determined using a non-flexible metric tape (maximum length: 2 m; precision: 0.1 cm).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 7, 2018)
  • Evaluation of dental caries [ Time Frame: 2 weeks ]
    Dental Caries - dental caries experience was recorded using the dmft index, which was employed following the recommendations of the WHO (WHO, 2007) to establish the prevalence and severity of caries.
  • Evaluation of saliva flow rate [ Time Frame: 4 weeks ]
    saliva flow rate - The salivary flow volume was calculated and expressed as ml/min. The following categories were considered in the analysis of salivary flow: < 0.1 ml/min = xerostomia; 0.1 to 0.6 ml/min = very low flow; 0.7 to 0.9 mL/min low flow; 1.0 to 2.0 ml/min = normal flow; and > 2.0 ml/min = high flow.
  • Evaluation of saliva buffering capacity [ Time Frame: 4 weeks ]
    salivary buffering capacity - an aliquot of 1 ml was transferred to a test tube with 3 ml of hydrochloric acid (HCl 5 mM) for titration and the determination of salivary buffering capacity (SBC). The saliva/acid solution was shaken in a q 220 vortex tube agitator (Quimis, Diadema, SP, Brazil) for 15 seconds. Next, pH was determined in a portable pH meter (KASVI K39-0014P, Curitiba, PR, Brazil) for the determination of the SBC. The following categories were considered: ≥ 5.5 = very good buffering capacity; 5.4 to 5.0 = good buffering capacity; 4.9 to 4.5 = medium good buffering capacity; 4.4 to 4.0 = low buffering capacity; and ≤ 3.9 very low buffering capacity .
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chronic Malnutrition and Oral Health Status in Children Aged One to Five Years
Official Title Chronic Malnutrition and Oral Health Status in Children Aged One to Five Years
Brief Summary Malnutrition is a public health problem that can exert a negative impact on the general and oral health of children. The aim of the present study was to evaluate the effect of chronic malnutrition on the oral health of children aged one to five years. An observational, analytical, cross-sectional study was conducted at the Nutritional Recovery Center and involved 82 children between 12 and 71 months of age. Nutritional status was evaluated using anthropometric indicators and oral health status was measured using the dmft index. Non-stimulated saliva was collected. Flow rate and buffering capacity was then measured with the aid of a pH meter.
Detailed Description Malnutrition is a public health problem that can exert a negative impact on the general and oral health of children. The aim of the present study was to evaluate the effect of chronic malnutrition on the oral health of children aged one to five years. An observational, analytical, cross-sectional study was conducted at the Nutritional Recovery Center and involved 82 children between 12 and 71 months of age. Nutritional status was evaluated using anthropometric indicators. The children were weighed on a previously calibrated electronic scale (capacity: 150 kg; precision: 100 g) barefoot and wearing light clothing in the presence of the mother or caregiver. Height was determined using a non-flexible metric tape (maximum length: 2 m; precision: 0.1 cm). Each measurement was made twice and the mean was used for the calculation height for age, weight for height and weight for age. The guidelines of the World Health Organization, were the reference for the evaluation of nutritional status. Oral health status was measured using the dmft index. The criteria adopted for the determination of prevalence followed by guidelines of the Oral Health Surveys - Basic Methods, 4th edition - described in the examiner's manual and annotator's manual produced by the coordination team of the Brazil Oral Health Project. Non-stimulated saliva was collected and Flow rate and buffering capacity was then measured with the aid of a pH meter. The salivary flow volume was calculated and expressed as ml/min. The following categories were considered in the analysis of salivary flow: < 0.1 ml/min = xerostomia; 0.1 to 0.6 ml/min = very low flow; 0.7 to 0.9 mL/min low flow; 1.0 to 2.0 ml/min = normal flow; and > 2.0 ml/min = high flow. The following categories were considered: ≥ 5.5 = very good buffering capacity; 5.4 to 5.0 = good buffering capacity; 4.9 to 4.5 = medium good buffering capacity; 4.4 to 4.0 = low buffering capacity; and ≤ 3.9 very low buffering capacity.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
saliva
Sampling Method Non-Probability Sample
Study Population This cross-sectional study will use a sample of children aged 12 to 71 months of the 7th Administrative Region of Maceió. This region is one of the poorest region in Maceió. The children's parents/guardians will be interviewed at the Center for Educational and Nutrition Recovery (CREN) in the city of Maceió, state of Alagoas, Brazil. The sample size was estimated considering a prevalence of malnutrition of about 20% in children under 6 years old, with statistical power of 80% and 95% significance, resulting in a sample of 100 children.
Condition Malnutrition, Child
Intervention
  • Diagnostic Test: Caries detection - dmtf index

    Dental caries experience was recorded using the dmft index, which was employed following the recommendations of the WHO to establish the prevalence and severity of caries. Active visible white spots were also recorded. The examinations were performed in duplicate for each child with the aim of establishing inter-examiner agreement using the Kappa statistic which demonstrated good agreement (K = 0.81).

    The criteria adopted for the determination of prevalence followed by guidelines of the Oral Health Surveys - Basic Methods, 4th edition (WHO, 1997) described in the examiner's manual and annotator's manual produced by the coordination team of the Brazil Oral Health Project. The severity and prevalence of dental caries were determined based on the dmft index.

  • Diagnostic Test: Saliva flow rate
    Samples of non-stimulated saliva were collected from the participants for five minutes using two aspirator tubes connected to a 15-ml Falcon tube. One aspirator tube was positioned under the child's tongue and the other was attached to the aspirator device. After five minutes, the amount of saliva was measured for the determination of salivary flow. Collections were performed between 9 and 11 am and the time of the last meal was recorded. At least a one-hour interval was required between the last meal and the collection of the saliva sample. The volume of saliva was measured. The salivary flow volume was calculated and expressed as ml/min. The following categories were considered in the analysis of salivary flow: < 0.1 ml/min = xerostomia; 0.1 to 0.6 ml/min = very low flow; 0.7 to 0.9 mL/min low flow; 1.0 to 2.0 ml/min = normal flow; and > 2.0 ml/min = high flow.
  • Diagnostic Test: Saliva Buffering Capacity
    an aliquot of 1 ml was transferred to a test tube with 3 ml of hydrochloric acid (HCl 5 mM) for titration and the determination of salivary buffering capacity (SBC). The saliva/acid solution was shaken in a q 220 vortex tube agitator (Quimis, Diadema, SP, Brazil) for 15 seconds. Next, pH was determined in a portable pH meter (KASVI K39-0014P, Curitiba, PR, Brazil) for the determination of the SBC. The following categories were considered: ≥ 5.5 = very good buffering capacity; 5.4 to 5.0 = good buffering capacity; 4.9 to 4.5 = medium good buffering capacity; 4.4 to 4.0 = low buffering capacity; and ≤ 3.9 very low buffering capacity.
Study Groups/Cohorts
  • Adequate nutritional status
    Dental caries experience was recorded using the dmft index. Active visible white spots were also recorded. Samples of non-stimulated saliva were collected from the participants for five minutes. The salivary flow volume was calculated and expressed as ml/min. After the measurement of salivary flow, an aliquot of 1 ml was transferred to a test tube with 3 ml of hydrochloric acid (HCl 5 mM) for titration and the determination of salivary buffering capacity (SBC).
    Interventions:
    • Diagnostic Test: Caries detection - dmtf index
    • Diagnostic Test: Saliva flow rate
    • Diagnostic Test: Saliva Buffering Capacity
  • Mild malnutrition
    Dental caries experience was recorded using the dmft index. Active visible white spots were also recorded. Samples of non-stimulated saliva were collected from the participants for five minutes. The salivary flow volume was calculated and expressed as ml/min. After the measurement of salivary flow, an aliquot of 1 ml was transferred to a test tube with 3 ml of hydrochloric acid (HCl 5 mM) for titration and the determination of salivary buffering capacity (SBC).
    Interventions:
    • Diagnostic Test: Caries detection - dmtf index
    • Diagnostic Test: Saliva flow rate
    • Diagnostic Test: Saliva Buffering Capacity
  • Moderate malnutrition
    Dental caries experience was recorded using the dmft index. Active visible white spots were also recorded. Samples of non-stimulated saliva were collected from the participants for five minutes. The salivary flow volume was calculated and expressed as ml/min. After the measurement of salivary flow, an aliquot of 1 ml was transferred to a test tube with 3 ml of hydrochloric acid (HCl 5 mM) for titration and the determination of salivary buffering capacity (SBC).
    Interventions:
    • Diagnostic Test: Caries detection - dmtf index
    • Diagnostic Test: Saliva flow rate
    • Diagnostic Test: Saliva Buffering Capacity
  • Severe malnutrition
    Dental caries experience was recorded using the dmft index. Active visible white spots were also recorded. Samples of non-stimulated saliva were collected from the participants for five minutes. The salivary flow volume was calculated and expressed as ml/min. After the measurement of salivary flow, an aliquot of 1 ml was transferred to a test tube with 3 ml of hydrochloric acid (HCl 5 mM) for titration and the determination of salivary buffering capacity (SBC).
    Interventions:
    • Diagnostic Test: Caries detection - dmtf index
    • Diagnostic Test: Saliva flow rate
    • Diagnostic Test: Saliva Buffering Capacity
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 7, 2018)
82
Original Actual Enrollment Same as current
Actual Study Completion Date July 27, 2017
Actual Primary Completion Date April 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Children aged one to five years enrolled at the Center for Educational and Nutrition Recovery.

Statement of informed consent signed by parents/guardians. Clinical diagnosis of malnutrition.

Exclusion Criteria:

Children aged one to five years not enrolled at the Center for Educational and Nutrition Recovery.

Children whose Parents/guardians did not sign a statement of informed consent.

Sex/Gender
Sexes Eligible for Study: All
Ages 12 Months to 71 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT03529500
Other Study ID Numbers Malnutrition and oral health
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: All IPD will be available after publication of results.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: After results publication.
Access Criteria: Depends on the journal criteria
Responsible Party Sandra Kalil Bussadori, University of Nove de Julho
Study Sponsor University of Nove de Julho
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Nove de Julho
Verification Date May 2018