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

Malnutrition, Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03529500
• Other study ID #: Malnutrition and oral health
• Status: Completed
• Start date: February 2, 2017
• Est. completion date: July 27, 2017

Study information

• Verified date: May 2018
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: July 27, 2017
• Est. primary completion date: April 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 71 Months

Eligibility

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.

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Malnutrition
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Nutritional Recovery Center	Maceió	Alagoas

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

References & Publications (19)

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. — View 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. Review. — View 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. Review. — View Citation

Corrêa-Faria P, Martins-Júnior 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/S1806-8324201300500002 — View 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. — View 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. — View 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. Review. — View Citation

Hallett KB, O'Rourke PK. Pattern and severity of early childhood caries. Community Dent Oral Epidemiol. 2006 Feb;34(1):25-35. — View 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. — View Citation

Johansson I, Lenander-Lumikari M, Saellström AK. Saliva composition in Indian children with chronic protein-energy malnutrition. J Dent Res. 1994 Jan;73(1):11-9. — View Citation

Moynihan P, Petersen PE. Diet, nutrition and the prevention of dental diseases. Public Health Nutr. 2004 Feb;7(1A):201-26. Review. — View Citation

Oliveira LB, Sheiham A, Bönecker 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. — View 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. — View 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. Review. — View 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. Epub 2007 Nov 5. — View Citation

Ramos CV, Dumith SC, César 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. — View 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. — View 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. — View 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. Epub 2006 May 22. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Height Measurement	Height was determined using a non-flexible metric tape (maximum length: 2 m; precision: 0.1 cm).	4 weeks
Secondary	Evaluation of dental caries	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.	2 weeks
Secondary	Evaluation of saliva flow rate	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.	4 weeks
Secondary	Evaluation of saliva buffering capacity	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 .	4 weeks