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

NCT03529500 | Completed DMC

• 1 other identifier: Malnutrition and oral health
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition, Child

Keywords

dental caries; saliva; child

Outcome Measures

Primary Outcomes (2)

• Weight Measurement

  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.

  4 weeks

• Height Measurement

  Height was determined using a non-flexible metric tape (maximum length: 2 m; precision: 0.1 cm).

  4 weeks

Secondary Outcomes (3)

• Evaluation of dental caries

  2 weeks

• Evaluation of saliva flow rate

  4 weeks

• Evaluation of saliva buffering capacity

  4 weeks

Study Arms (4)

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).

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).

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).

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).

Diagnostic Test: Caries detection - dmtf index; Diagnostic Test: Saliva flow rate; Diagnostic Test: Saliva Buffering Capacity

Interventions

Caries detection - dmtf index DIAGNOSTIC_TEST

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.

Adequate nutritional status; Mild malnutrition; Moderate malnutrition; Severe malnutrition

Saliva flow rate DIAGNOSTIC_TEST

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.

Adequate nutritional status; Mild malnutrition; Moderate malnutrition; Severe malnutrition

Saliva Buffering Capacity DIAGNOSTIC_TEST

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.

Adequate nutritional status; Mild malnutrition; Moderate malnutrition; Severe malnutrition

Eligibility Criteria

• Age: 12 Months - 71 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Nutritional Recovery Center

Maceió, Alagoas, 57072-740, Brazil

Location

Related Publications (19)

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• Psoter WJ, Spielman AL, Gebrian B, St Jean R, Katz RV. Effect of childhood malnutrition on salivary flow and pH. Arch Oral Biol. 2008 Mar;53(3):231-7. doi: 10.1016/j.archoralbio.2007.09.007. Epub 2007 Nov 5.

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• Samnieng P, Ueno M, Shinada K, Zaitsu T, Wright FA, Kawaguchi Y. Association of hyposalivation with oral function, nutrition and oral health in community-dwelling elderly Thai. Community Dent Health. 2012 Mar;29(1):117-23.

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Biospecimen

Retention: NONE RETAINED

saliva

MeSH Terms

Conditions

Child Nutrition Disorders; Dental Caries

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 15, 2018
• First Posted: May 18, 2018
• Study Start: February 2, 2017
• Primary Completion: April 27, 2017
• Study Completion: July 27, 2017
• Last Updated: May 18, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After results publication.
• Access Criteria: Depends on the journal criteria

Locations

BR (1)