Chronic Malnutrition and Oral Health Status in Children Aged One to Five Years
NCT ID: NCT03529500
Last Updated: 2018-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
82 participants
OBSERVATIONAL
2017-02-02
2017-07-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Malnutrition on Primary and Permanent Dentation
NCT04747028
Third Molar: Caries, Periodontal Desease and Quality of Life
NCT06081816
Assessment of Changes in Oral Health-related Quality of Life , Oral Hygiene Status and Body Growth in CSHCN Following Dental Treatment Under General Anaesthesia
NCT04861675
Oral Health Educational Methods in Adolescence
NCT03216746
Caries in Adolescents (Karies Hos Ungdom)
NCT05935813
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
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.
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).
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.
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).
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.
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).
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Statement of informed consent signed by parents/guardians. Clinical diagnosis of malnutrition.
Exclusion Criteria
Children whose Parents/guardians did not sign a statement of informed consent.
12 Months
71 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Nove de Julho
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sandra Kalil Bussadori
Clinical Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nutritional Recovery Center
Maceió, Alagoas, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Malnutrition and oral health
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.