Study of Oral Conditions in Indigenous Populations in the State of Roraima - Brazil

September 4, 2018 updated by: CAIO VINICIUS GONÇALVES ROMAN TORRES, Universidade Metropolitana de Santos
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

Study Overview

Detailed 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.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • SP
      • Santos, SP, Brazil, 11015001
        • Caio Vinicius Gonçalves Roman Torres

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In the present study, about 200 indigenous people of the Yanomami, Macuxi and Wapixana ethnic groups of both genders, aged between 18 and 75 years, were evaluated in their respective communities located in the state of Roraima.

Clinical parameters evaluated were Depth of Depth (PS), Clinical Insertion Level (NCI), Index of Plaque (PI), Bleeding Index (IS), Caries Index, Lost and Sealed Index (DMFT); The examiners were previously calibrated by means of periodontal clinical parameters measurements and compared intra-examiner and inter-examiner. Data were tabulated and received adequate statistical treatment (p <0.05).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Yanomamis
Yanomami Indians, Anamnesis and oral clinical examination
A detailed anamnesis should be carried out in order to know the habits, the presence of systemic pathologies, the use of medication
Clinical examination should be carried out evaluating the presence of caries, tooth loss, periodontal condition, occlusal factors
Macuxi
Macuxi Indians, Anamnesis and oral clinical examination
A detailed anamnesis should be carried out in order to know the habits, the presence of systemic pathologies, the use of medication
Clinical examination should be carried out evaluating the presence of caries, tooth loss, periodontal condition, occlusal factors
Wapixana
Wapixana Indians, Anamnesis and oral clinical examination
A detailed anamnesis should be carried out in order to know the habits, the presence of systemic pathologies, the use of medication
Clinical examination should be carried out evaluating the presence of caries, tooth loss, periodontal condition, occlusal factors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing Deep
Time Frame: 1 day
probing deep in six points/teeth
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival index
Time Frame: 1 day
gingival index in four points / teeth
1 day
Plaque index
Time Frame: 1 day
plaque index in four points/teeth
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2017

Primary Completion (Actual)

May 2, 2017

Study Completion (Actual)

October 2, 2017

Study Registration Dates

First Submitted

September 4, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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