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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03660410
Other study ID # SantosMU03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2, 2017
Est. completion date October 2, 2017

Study information

Verified date September 2018
Source Santos Metropolitan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this cross - sectional observational study will be to evaluate the oral conditions of indigenous people in the state of Roraima, comparing habits and hygiene conditions in each ethnicity evaluated. This project was submitted to the Coordination of the Yanomami Indigenous Special Sanitary District, the CONDISI presidency and the CASAI leadership. Around 200 indigenous people from the aforementioned ethnic groups, of both sexes, aged between 18 and 75 years, will be evaluated


Description:

The indigenous population, as well as the non-indigenous population, has been plagued by oral diseases throughout its history. Within the population in general, periodontal diseases exhibit great expressiveness, they appear as the most common chronic diseases, but in the indigenous population there is a certain epidemiological invisibility. In this population there is a shortage in the studies, some of these show that the higher prevalences of insertion level and depth of probing occur in individuals with more advanced age and that they are afflicted with periodontal diseases. The objective of this cross - sectional observational study will be to evaluate the oral conditions of indigenous people in the state of Roraima, comparing habits and hygiene conditions in each ethnicity evaluated. This project was submitted to the Coordination of the Yanomami Indigenous Special Sanitary District, the CONDISI presidency and the CASAI leadership. Around 200 indigenous people from the aforementioned ethnic groups, of both sexes, aged between 18 and 75 years, will be evaluated, with voluntary participation and by means of the signature of the free and informed consent form of the same or its person in charge. Due to the difficulties encountered in the indigenous communities in relation to the distance from health care, where there are no care centers near their residence and thus not obtaining the information necessary for basic health care, with the aggravation of contact with the culture. Indigenous people with often deleterious eating habits, we expect to find a population with many oral health problems, such as periodontal disease, dental caries and tooth loss. The insufficiency of studies with appropriate methodology gives the indigenous peoples of Latin America an epidemiological invisibility that impairs the production of knowledge about oral health conditions and the elaboration of strategies to prevent oral diseases and promote health in these populations.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date October 2, 2017
Est. primary completion date May 2, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- individuals of the Macuxi, Yanomami and Wapixana ethnic groups aged between 18 and 75 years

Exclusion Criteria:

- Individuals who have included periodontal treatment in the last 6 months;

- hospitalized with antibiotic therapy in the last 6 months;

- who need medication for clinical evaluation and

- total edentulous individuals.

Study Design


Intervention

Other:
Anamnesis
A detailed anamnesis should be carried out in order to know the habits, the presence of systemic pathologies, the use of medication
Oral clinical examination
Clinical examination should be carried out evaluating the presence of caries, tooth loss, periodontal condition, occlusal factors

Locations

Country Name City State
Brazil Caio Vinicius Gonçalves Roman Torres Santos SP

Sponsors (1)

Lead Sponsor Collaborator
Santos Metropolitan University

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Probing Deep probing deep in six points/teeth 1 day
Secondary Gingival index gingival index in four points / teeth 1 day
Secondary Plaque index plaque index in four points/teeth 1 day
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