Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001239954
Ethics application status
Approved
Date submitted
30/11/2011
Date registered
5/12/2011
Date last updated
5/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Association between oral health and nutritional status in Guarani indigenous people from Florianopolis region.
Scientific title
Indigenous population: relationship between oral health and nutritional status.
Secondary ID [1] 273496 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral health 279289 0
nutritional status 279290 0
Condition category
Condition code
Oral and Gastrointestinal 279485 279485 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Diet and Nutrition 279486 279486 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Oral health and comfort in the oral cavity are pre-requisites for a good chewing function and may have an impact on food quality and nutritional status. These influences may be related to quantity, quality and consistency of food eaten. The study of the relationship between oral health and nutritional status is scarce in the different age groups and virtually nonexistent among the indigenous population. Associated with this relation between eating habits and oral health, are linked to socio-economic, cultural and psychological and are influenced by the practices of health care in the family routine. Despite the nutritional profiles and the influence of changes in the way of life of indigenous peoples are largely unknown, the nutritional question is a dimension privileged to seek to identify and understand the consequences in their living conditions, health and nutrition. Cross-sectional study, with two years of duration, was carried out with Guarani indigenous people from Florianopolis region. The sample consisted of 251 children and adolescents and 123 adults. In this study was measured the association between oral health and nutritional status. The oral health status was assessed by a dmft index (decayed, missing or filled primary teeth) and DMFT index (permanent teeth decayed, missing and filled) determined using the codes and criteria established by the World Health Organization (1997) only once. The classification of nutritional status was performed according to criteria adopted by the World Health Organization (WHO, 2006, 2007), based on anthropometric indices, height-for-age (H/A), weight-for-age (W/I) and Body Mass Index (BMI) for age. The nutritional status for adults and elderly patients was classified according to the cutoffs recommended by World Health Organization (WHO, 2008).
Intervention code [1] 283813 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286050 0
Assessment of oral health status in Indigenous population:

Oral health status was assessed by a single calibrated operator under natural light. The dmft index (decayed, missing or filled primary teeth) and DMFT index (permanent teeth decayed, missing and filled) were determined using the codes and criteria established by the World Health Organization (1997). The oral health status was classified into satisfactory and unsatisfactory, according to age, adapted indexes, established for oral health by the WHO (1997) and SB-Brazil Project (2004). For ages between five and under twelve years was considered satisfactory when dmft/DMFT equal to zero and unsatisfactory when dmft/DMFT more than zero. For individuals with twelve years was considered satisfactory when DMFT less than or equal one and unsatisfactory when DMFT more than one. For ages more than twelve years and less than or equal to nineteen years was considered satisfactory when Missing Teeth (MT equal zero) and unsatisfactory when MT more than zero. For ages between twenty years and less than or equal to sixty-five years was considered satisfactory when DMFT less than or equal 13 and unsatisfactory when DMFT more than 13. For individuals with more than to sixty-five years was considered satisfactory when DMFT less than or equal 20 and unsatisfactory when DMFT more than 20. Habits related to oral health care were investigated through an interview with questions that relate to the following variables: frequency of consumption of foods with sugar and visit to the dentist. The oral health status was classified in relation to the risk of dental caries, of periodontal disease, and changes in soft tissues employing the codes and criteria recognized by the Office for Programmes and Development of Health Policies (CODDEPS, 2006).
Timepoint [1] 286050 0
Indigenous population was evaluated only once at the end of study.
Primary outcome [2] 286051 0
Assessment of nutritional status in Indigenous population:

For the evaluation of body weight was used a portable electronic scale (Marte MS-160 with platform, Sao Paulo, Sao Paulo, Brazil), with a sensibility of 50 g and maximum capacity of 160 kg. To check this, was following this procedures: light clothes and without shoes, the individual remained standing on the center of scale platform, with your weight evenly distributed on both feet, with arms side of the body. Weight was recorded in kilograms (kg) and grams (g) (WHO, 1995). For children under 2 years was used a digital pediatric scale (Filizola Baby, Sao Paulo, Sao Paulo, Brazil) 15 kg, with a minimum load of 125 g and divisions of 5 g. To check the height was used an anthropometer (Alturaexata, Belo Horizonte, Minas Gerais, Brazil), with a precision of 0.1 cm, as recommended by WHO (1995). The classification of nutritional status was performed according to criteria adopted by the World Health Organization (WHO, 2006, 2007), based on anthropometric indices, height-for-age (H/A), weight-for-age (W/I) and Body Mass Index (BMI) for age. Being classified as: H/A - stunted (z score less than minor two Stander (S) Deviation (D) and normal height (z score more than minor two SD); and W/A - malnutrition (z score less than minor two SD) for normal weight (with Z scores between minor two SD and plus two SD), and overweight those children with Z scores more than plus two SD. For this study are compared with previous data was also used the parameters of the National Center for Health Statistics (NCHS) published by Hamill et al. (1979). Being classified as: W/A - malnourished children with Z scores less than minor two SD; normal weight when Z scores between minor two SD and plus two SD; and overweight those children with Z scores more than plus two SD. The diagnosis of nutritional status was also determined from the percentages proposed by the National Center for Health Statistics/Centers for Disease Control and Prevention (NCHS/CDC, 2000), for comparison with the WHO (2007). It was considered the age of 12 in 12 months. The nutritional status for adults and elderly patients was classified according to the cut offs recommended by World Health Organization (WHO, 2008): underweight (BMI less than 18.5 kg/square metre), normal weight (BMI equal to 18.50 until 24.99 kg/ square metre), overweight (BMI equal to 25.00 until 29.99 kg/ square metre), obesity class I (BMI equal 30.00 until 34.99 kg/ square metre), class II obesity (BMI equal 35.00 until 39.99 kg/ square metre), class III obese (BMI more than or equal to 40.00 kg/ square metre). The triceps skinfold (TSF) was collected with the skinfold compass (Lange Skinfold Caliper, Santa Cruz, California, USA) in the right hemibody, according to the methodology of the World Health Organization (1995). This measurement was performed in triplicate and the mean was used in the computations. For TSF were used the reference values of Frisancho (1981). Nutritional status was assessed according to TSF distributed in percentiles: less than percentile 5 equal malnutrition; more than or equal to percentile 5 and less than percentile 85 equal eutrophy; more than or equal percentile 85 and less than percentile 95 equal overweight; more than or equal percentile 95 equal obesity). The waist circumference (WC) was collected using the procedure described by Callaway et al. (1991). Were used a flexible tape measure with a precision of 1 mm. The values of waist circumference for children and adolescents are presented as percentiles, with the cutoff points by age and sex according to Cook et al. (2009). The classification of central obesity in adults and older met the criteria suggested by WHO (2000). To measurement the circumference of the calf was used the methodology of the World Health Organization (1995). Was used a tape measure graduated, flexible, inelastic, with an accuracy of 0.1 cm. There were two measures, by calculating the arithmetic mean of the same. The cut off point for circumference of the calf of less than 30.5 cm was considered malnutrition, according to Bonnefoy et al., 2002.
Timepoint [2] 286051 0
Indigenous population was evaluated only once at the end of study.
Secondary outcome [1] 295042 0
Nil
Timepoint [1] 295042 0
Nil

Eligibility
Key inclusion criteria
Individuals and/or guardians indigenous who agreed to participate in the study after reading and signing the consent form free and clear.
Minimum age
1 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant and individuals that suffering from organic limitations that compromised the data collection.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
374
Accrual to date
Final
Recruitment outside Australia
Country [1] 3985 0
Brazil
State/province [1] 3985 0
Santa Catarina

Funding & Sponsors
Funding source category [1] 284285 0
Self funded/Unfunded
Name [1] 284285 0
Country [1] 284285 0
Primary sponsor type
Individual
Name
Emilia Addison Machado Moreira
Address
Universidade Federal de Santa Catarina (UFSC), Centro de Ciencia da Saude, Departamento de Nutricao - Campus Reitor Joao David Ferreira Lima, Trindade, s/n, Florianopolis, Santa Catarina, ZIP: 88.040-970.
Country
Brazil
Secondary sponsor category [1] 283237 0
Individual
Name [1] 283237 0
Arlete Catarina Tittoni Corso
Address [1] 283237 0
Universidade Federal de Santa Catarina (UFSC), Centro de Ciencia da Saude, Departamento de Nutricao - Campus Reitor Joao David Ferreira Lima, Trindade, s/n, Florianopolis, Santa Catarina, ZIP: 88.040-970.
Country [1] 283237 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286244 0
Ethics Committe for Researchs with Humans of Federal University of Santa Catarina (UFSC).
Ethics committee address [1] 286244 0
Ethics committee country [1] 286244 0
Brazil
Date submitted for ethics approval [1] 286244 0
13/02/2006
Approval date [1] 286244 0
24/04/2006
Ethics approval number [1] 286244 0
024/2006
Ethics committee name [2] 286245 0
National Committee for Ethics in Research.
Ethics committee address [2] 286245 0
Ethics committee country [2] 286245 0
Brazil
Date submitted for ethics approval [2] 286245 0
24/04/2006
Approval date [2] 286245 0
28/05/2007
Ethics approval number [2] 286245 0
404/2007
Ethics committee name [3] 286246 0
Authorization of FUNAI for entry into indigenous lands.
Ethics committee address [3] 286246 0
Ethics committee country [3] 286246 0
Brazil
Date submitted for ethics approval [3] 286246 0
28/05/2007
Approval date [3] 286246 0
13/08/2007
Ethics approval number [3] 286246 0
0905/2007

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33462 0
Address 33462 0
Country 33462 0
Phone 33462 0
Fax 33462 0
Email 33462 0
Contact person for public queries
Name 16709 0
Emilia Addison Machado Moreira
Address 16709 0
Universidade Federal de Santa Catarina (UFSC), Centro de Ciencia da Saude, Departamento de Nutricao, Campus Reitor Joao David Ferreira Lima, Trindade, s/n, Florianopolis, Santa Catarina, ZIP: 88040-970.
Country 16709 0
Brazil
Phone 16709 0
+55 (48) 3721-9784 (for Santa Catarina, Brazil)
Fax 16709 0
+55 (48) 3721-9542 (for Santa Catarina, Brazil)
Email 16709 0
[email protected]
Contact person for scientific queries
Name 7637 0
Emilia Addison Machado Moreira
Address 7637 0
Universidade Federal de Santa Catarina (UFSC), Centro de Ciencia da Saude, Departamento de Nutricao, Campus Reitor Joao David Ferreira Lima, Trindade, s/n, Florianopolis, Santa Catarina, ZIP: 88040-970.
Country 7637 0
Brazil
Phone 7637 0
+55 (48) 3721-9784 (for Santa Catarina, Brazil)
Fax 7637 0
+55 (48) 3721-9542 (for Santa Catarina, Brazil)
Email 7637 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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