Malnutrition, ChildNCT03529500
Chronic Malnutrition and Oral Health Status in Children Aged One to Five Years
An observational study of Malnutrition, Child, run by University of Nove de Julho at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 12 to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Child
- What is being tested?
- Caries detection - dmtf index, Saliva flow rate and Saliva Buffering Capacity
- Type of treatment
- Pill or oral medicine
- How many people
- 82 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Feb 2017to 27 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 71 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Malnutrition, Child
- Being tested
- Caries detection - dmtf index, Saliva flow rate, Saliva Buffering Capacity
- Keywords
- dental caries, saliva, child
- Medical subject headings
- Child Nutrition Disorders, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caries detection - dmtf indexDiagnostic 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.
Saliva flow rateDiagnostic 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.
Saliva Buffering CapacityDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: Diagnostic Test: Caries detection - dmtf index; Diagnostic Test: Saliva flow rate; Diagnostic Test: Saliva Buffering Capacity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Height Measurement
Height was determined using a non-flexible metric tape (maximum length: 2 m; precision: 0.1 cm).
Measured: 4 weeks
Secondary outcomes (3)
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.
Measured: 2 weeks
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.
Measured: 4 weeks
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 .
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start2 Feb 2017
- Primary completion27 Apr 2017
- Study completion27 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Malnutrition, ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529500
- Sponsor's protocol ID
- Malnutrition and oral health
- Status last verified
- May 2018
- First submitted
- 15 Apr 2018
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD will be available after publication of results.
Publications
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.
PubMed 18207566Folayan 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.
PubMed 26123713Hallett 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.
PubMed 16423028Jamelli 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.
PubMed 20480058Oliveira 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.
PubMed 18186730Palmer 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.
PubMed 20858780Ramos 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.
PubMed 25449789Torres 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.
PubMed 16729168Bissar 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.
PubMed 24114252Brouwer 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.
PubMed 26464398Correa-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.
PubMed 23780495Das 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.
PubMed 24403793Fontana 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.
PubMed 26063551Johansson 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.
PubMed 8294612Moynihan P, Petersen PE. Diet, nutrition and the prevention of dental diseases. Public Health Nutr. 2004 Feb;7(1A):201-26. doi: 10.1079/phn2003589.
PubMed 14972061
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Malnutrition and Oral Health Status in Children Aged One to Five Years
- ClinicalTrials.gov ID
- NCT03529500
- Acronym / sponsor ID
- Malnutrition and oral health
- Conditions
- Malnutrition, Child
- Keywords
- dental caries, saliva, child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 27 Apr 2017 (actual)
- Study completion
- 27 Jul 2017 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adequate nutritional status | – | Diagnostic Test: Caries detection - dmtf index, Diagnostic Test: Saliva flow rate, Diagnostic Test: Saliva Buffering CapacityDental 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). |
| Mild malnutrition | – | Diagnostic Test: Caries detection - dmtf index, Diagnostic Test: Saliva flow rate, Diagnostic Test: Saliva Buffering CapacityDental 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). |
| Moderate malnutrition | – | Diagnostic Test: Caries detection - dmtf index, Diagnostic Test: Saliva flow rate, Diagnostic Test: Saliva Buffering CapacityDental 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). |
| Severe malnutrition | – | Diagnostic Test: Caries detection - dmtf index, Diagnostic Test: Saliva flow rate, Diagnostic Test: Saliva Buffering CapacityDental 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). |
Who may qualify
- Ages
- 12 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caries detection - dmtf indexDental 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 | Adequate nutritional status, Mild malnutrition, Moderate malnutrition, Severe malnutrition |
| Saliva flow rateSamples 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 | Adequate nutritional status, Mild malnutrition, Moderate malnutrition, Severe malnutrition |
| Saliva Buffering Capacityan 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. | Diagnostic test | Adequate nutritional status, Mild malnutrition, Moderate malnutrition, Severe malnutrition |
Primary outcome
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).
3 secondary outcomes
Evaluation of dental caries
Time frame: 2 weeks
Evaluation of saliva flow rate
Time frame: 4 weeks
Evaluation of saliva buffering capacity
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Background: PubMed 18207566Black 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.
- Background: PubMed 26123713Folayan 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.
- Background: PubMed 16423028Hallett 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.
- Background: PubMed 20480058Jamelli 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.
- Background: PubMed 18186730Oliveira 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.
- Background: PubMed 20858780Palmer 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.
- Background: PubMed 25449789Ramos 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.
- Background: PubMed 16729168Torres 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.
- Results publication: PubMed 24114252Bissar 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.
- Results publication: PubMed 26464398Brouwer 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.
- Results publication: PubMed 23780495Correa-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.
- Results publication: PubMed 24403793Das 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.
- Individual participant dataSharing planned: Yes. All IPD will be available after publication of results.
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Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children
Small Intestine Bacterial Overgrowth
Recruiting
Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition
Acute Malnutrition With no Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, Child, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Measurement (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03529500, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.