Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000781842
Ethics application status
Approved
Date submitted
13/07/2012
Date registered
24/07/2012
Date last updated
24/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Association between oral health and nutritional status in three generations.
Scientific title
Understanding aging: reflection of nutritional status on the oral conditions in three generations.
Secondary ID [1] 280844 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral health 286909 0
Nutritional status 286910 0
Condition category
Condition code
Oral and Gastrointestinal 287234 287234 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Diet and Nutrition 287235 287235 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
The Brazilian population is aging at an increasing pace, especially in recent decades. This increase in life expectancy is due to several factors that together has provided an improvement in living conditions. The result is a significant change in the age of the population pyramid distribution, with a reduction in birth rate and aging population. The feed can affect the development and cooperate in the progression of diseases of the oral cavity, while these diseases can result in tooth loss, which in turn, within this cycle, may influence the choice of food. Cross-sectional study with 54 subjects (grandparent-elderly), of both sexes, each with his child (54 adult) and grandchild (54 child). In this study was measured the association between oral condition and nutritional status. The oral health status was determined using the codes and criteria established by the World Health Organization (1997) and assessed by a dmft index (decayed, missing or filled primary teeth) for children, DMFT index (permanent teeth decayed, missing and filled) for adults and the number of functional units present in the oral cavity was used for grandparents. The classification of nutritional status was performed according to criteria adopted by World Health Organization (WHO, 2008) for adults and the elderly and, for children was used the criteria recommended by WHO, 2006, 2007, based on Body Mass Index (BMI). The approximate duration of assessment in each participant was of the 2 hours and on one occasion only.
Intervention code [1] 285265 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287517 0
Assessment of oral health status
Oral health status was assessed by a single calibrated operator under natural light. The dmft index (decayed, missing or filled primary teeth) for children, DMFT index (permanent teeth decayed, missing and filled) for adults and the number of functional units present in the oral cavity was used for grandparents, were determined using the codes and criteria established by the World Health Organization (1999). 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 zero and unsatisfactory when dmft/DMFTmore than zero. For ages between twenty years and less than or equal to sixty-five years was considered satisfactory when DMFT less or equal to 13 and unsatisfactory when DMFT more than 13. For individuals with more than to sixty-five years was considered satisfactory when have 10-14 functional units dental and unsatisfactory when less or equal to 10 functional units dental. 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.
Timepoint [1] 287517 0
Evaluated only once at the end of study.
Primary outcome [2] 287518 0
Assessment of nutritional status
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). To check the height was used a anthropometer (Alturaexata, Belo Horizonte, Minas Gerais, Brazil), with a precision of 0.1 cm, as recommended by WHO (1995). With the head in the line of sight perpendicular to the body, ie, parallel to the ground, the individual was instructed to inhale deeply, and in apnea was taken the measure of stature. The reference was the measure the highest point of the head with sufficient pressure to compress the hair. There were two measures, by calculating the arithmetic mean of these (WHO, 1995). The classification of nutritional status was performed according to criteria adopted by World Health Organization (WHO, 2008) for adults and the elderly and, for children was used the criteria recommended by WHO, 2006, 2007, based on Body Mass Index (BMI). 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). For TSF were used the reference values of Frisancho (1981). The waist circumference (WC) was collected using the procedure described by Callaway et al. (1991). Were used a flexible tape measure with an precision of 1 mm. The values of waist circumference for children and adolescents are presented as percentiles, with the cut off points by age and sex according to Taylor et al. (2000). 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. Habits eating were investigated through an interview.
Timepoint [2] 287518 0
Evaluated only once at the end of study.
Secondary outcome [1] 298308 0
Socio-economic status
The sample was classified according to a criterion adapted from the Brazil economic classification, developed by the Associacao Brasileira de Empresas de Pesquisa (2003), that classifies the population in economic classes A, B, C, D and E, as determined by their spending power and level of schooling of the head of the family.
Timepoint [1] 298308 0
Evaluated only once at the end of study.

Eligibility
Key inclusion criteria
Aged 60 years and above, the cut-off point for the definition of elderly recognised by the World Health Organization (1989), together with members of their family, following a trigenerational lineage: their son/daughter – adult, and their grandchild- child, aged 5 to 12 years (age groups recognised by the World Health Organization (1999) for evaluations of oral health).
Minimum age
5 Years
Maximum age
84 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Absence of three generations (child and grandchild) who did not reside in Florianopolis, presence of diseases that prevented the exams.

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
7/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
162
Accrual to date
Final
Recruitment outside Australia
Country [1] 4404 0
Brazil
State/province [1] 4404 0
Santa Catarina

Funding & Sponsors
Funding source category [1] 285626 0
Government body
Name [1] 285626 0
Conselho Nacional de Desenvolvimento Cientifico e Tecnologico (CNPq)
Country [1] 285626 0
Brazil
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: 88.049-970.
Country
Brazil
Secondary sponsor category [1] 284461 0
Individual
Name [1] 284461 0
Michelle Soares Rauen
Address [1] 284461 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: 88.049-970.
Country [1] 284461 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287624 0
Ethics Committe for Researchs with Humans of Federal University of Santa Catarina (UFSC).
Ethics committee address [1] 287624 0
Ethics committee country [1] 287624 0
Brazil
Date submitted for ethics approval [1] 287624 0
15/09/2004
Approval date [1] 287624 0
07/03/2005
Ethics approval number [1] 287624 0
320/2004

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

Contacts
Principal investigator
Name 34434 0
Address 34434 0
Country 34434 0
Phone 34434 0
Fax 34434 0
Email 34434 0
Contact person for public queries
Name 17681 0
Emilia Addison Machado Moreira
Address 17681 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 17681 0
Brazil
Phone 17681 0
+55 (48) 3721-9784 (for Santa Catarina, Brazil)
Fax 17681 0
+55 (48) 3721-9542 (for Santa Catarina, Brazil)
Email 17681 0
[email protected]
Contact person for scientific queries
Name 8609 0
Emilia Addison Machado Moreira
Address 8609 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 8609 0
Brazil
Phone 8609 0
+55 (48) 3721-9784 (for Santa Catarina, Brazil)
Fax 8609 0
+55 (48) 3721-9542 (for Santa Catarina, Brazil)
Email 8609 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.