NCT03660410

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

2 months

First QC Date

September 4, 2018

Last Update Submit

September 4, 2018

Conditions

Keywords

indians, south americanperiodontal diseasedental caries

Outcome Measures

Primary Outcomes (1)

  • Probing Deep

    probing deep in six points/teeth

    1 day

Secondary Outcomes (2)

  • Gingival index

    1 day

  • Plaque index

    1 day

Study Arms (3)

Yanomamis

Yanomami Indians, Anamnesis and oral clinical examination

Other: AnamnesisOther: Oral clinical examination

Macuxi

Macuxi Indians, Anamnesis and oral clinical examination

Other: AnamnesisOther: Oral clinical examination

Wapixana

Wapixana Indians, Anamnesis and oral clinical examination

Other: AnamnesisOther: Oral clinical examination

Interventions

A detailed anamnesis should be carried out in order to know the habits, the presence of systemic pathologies, the use of medication

MacuxiWapixanaYanomamis

Clinical examination should be carried out evaluating the presence of caries, tooth loss, periodontal condition, occlusal factors

MacuxiWapixanaYanomamis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caio Vinicius Gonçalves Roman Torres

Santos, São Paulo, 11015001, Brazil

Location

MeSH Terms

Conditions

DiseasePeriodontal DiseasesDental Caries

Interventions

Immunologic MemoryRestraint, Physical

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMouth DiseasesStomatognathic DiseasesTooth DemineralizationTooth Diseases

Intervention Hierarchy (Ancestors)

Adaptive ImmunityImmunityImmune System PhenomenaBehavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 6, 2018

Study Start

March 2, 2017

Primary Completion

May 2, 2017

Study Completion

October 2, 2017

Last Updated

September 6, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations