Clinical trial NCT03529500: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition, Child
Keywords: dental caries
saliva
child
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 82
Sex: ALL
Minimum age (years): 12
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
measure: Weight Measurement
timeFrame: 4 weeks
measure: Height Measurement
timeFrame: 4 weeks
Secondary outcomes:
measure: Evaluation of dental caries
timeFrame: 2 weeks
measure: Evaluation of saliva flow rate
timeFrame: 4 weeks
measure: Evaluation of saliva buffering capacity
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Maceió
country: Brazil
facility: Nutritional Recovery Center
state: Alagoas
Study officials:
References:
citation: Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.
citation: Folayan MO, Kolawole KA, Oziegbe EO, Oyedele T, Oshomoji OV, Chukwumah NM, Onyejaka N. Prevalence, and early childhood caries risk indicators in preschool children in suburban Nigeria. BMC Oral Health. 2015 Jun 30;15:72. doi: 10.1186/s12903-015-0058-y.
citation: Hallett KB, O'Rourke PK. Pattern and severity of early childhood caries. Community Dent Oral Epidemiol. 2006 Feb;34(1):25-35. doi: 10.1111/j.1600-0528.2006.00246.x.
citation: Jamelli SR, Rodrigues CS, de Lira PI. Nutritional status and prevalence of dental caries among 12-year-old children at public schools: a case-control study. Oral Health Prev Dent. 2010;8(1):77-84.
citation: Oliveira LB, Sheiham A, Bonecker M. Exploring the association of dental caries with social factors and nutritional status in Brazilian preschool children. Eur J Oral Sci. 2008 Feb;116(1):37-43. doi: 10.1111/j.1600-0722.2007.00507.x.
citation: Palmer CA, Kent R Jr, Loo CY, Hughes CV, Stutius E, Pradhan N, Dahlan M, Kanasi E, Arevalo Vasquez SS, Tanner AC. Diet and caries-associated bacteria in severe early childhood caries. J Dent Res. 2010 Nov;89(11):1224-9. doi: 10.1177/0022034510376543. Epub 2010 Sep 21.
citation: Ramos CV, Dumith SC, Cesar JA. Prevalence and factors associated with stunting and excess weight in children aged 0-5 years from the Brazilian semi-arid region. J Pediatr (Rio J). 2015 Mar-Apr;91(2):175-82. doi: 10.1016/j.jped.2014.07.005. Epub 2014 Nov 6.
citation: Torres SR, Nucci M, Milanos E, Pereira RP, Massaud A, Munhoz T. Variations of salivary flow rates in Brazilian school children. Braz Oral Res. 2006 Jan-Mar;20(1):8-12. doi: 10.1590/s1806-83242006000100003. Epub 2006 May 22.
citation: Bissar A, Schiller P, Wolff A, Niekusch U, Schulte AG. Factors contributing to severe early childhood caries in south-west Germany. Clin Oral Investig. 2014;18(5):1411-8. doi: 10.1007/s00784-013-1116-y. Epub 2013 Oct 11.
citation: Brouwer F, Askar H, Paris S, Schwendicke F. Detecting Secondary Caries Lesions: A Systematic Review and Meta-analysis. J Dent Res. 2016 Feb;95(2):143-51. doi: 10.1177/0022034515611041. Epub 2015 Oct 13.
citation: Correa-Faria P, Martins-Junior PA, Vieira-Andrade RG, Marques LS, Ramos-Jorge ML. Factors associated with the development of early childhood caries among Brazilian preschoolers. Braz Oral Res. 2013 Jul-Aug;27(4):356-62. doi: 10.1590/S1806-83242013005000021.
citation: Das D, Misra J, Mitra M, Bhattacharya B, Bagchi A. Prevalence of dental caries and treatment needs in children in coastal areas of West Bengal. Contemp Clin Dent. 2013 Oct;4(4):482-7. doi: 10.4103/0976-237X.123048.
citation: Fontana M. The Clinical, Environmental, and Behavioral Factors That Foster Early Childhood Caries: Evidence for Caries Risk Assessment. Pediatr Dent. 2015 May-Jun;37(3):217-25.
citation: Johansson I, Lenander-Lumikari M, Saellstrom AK. Saliva composition in Indian children with chronic protein-energy malnutrition. J Dent Res. 1994 Jan;73(1):11-9. doi: 10.1177/00220345940730010101.
citation: Moynihan P, Petersen PE. Diet, nutrition and the prevention of dental diseases. Public Health Nutr. 2004 Feb;7(1A):201-26. doi: 10.1079/phn2003589.
citation: Psoter WJ, Reid BC, Katz RV. Malnutrition and dental caries: a review of the literature. Caries Res. 2005 Nov-Dec;39(6):441-7. doi: 10.1159/000088178.
citation: 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.
citation: 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.
citation: Sheetal A, Hiremath VK, Patil AG, Sajjansetty S, Kumar SR. Malnutrition and its oral outcome - a review. J Clin Diagn Res. 2013 Jan;7(1):178-80. doi: 10.7860/JCDR/2012/5104.2702. Epub 2013 Jan 1.