Diagnosis, OralNCT03660410
Study of Oral Conditions in Indigenous Populations in the State of Roraima - Brazil
An observational study of Diagnosis, Oral and Periodontal Diseases, run by Universidade Metropolitana de Santos at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diagnosis, Oral, Periodontal Diseases, Caries, Dental
- What is being tested?
- Anamnesis and Oral clinical examination
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Mar 2017to 2 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- individuals of the Macuxi, Yanomami and Wapixana ethnic groups aged between 18 and 75 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Diagnosis, Oral, Periodontal Diseases, Caries, Dental
- Being tested
- Anamnesis, Oral clinical examination
- Keywords
- indians, south american, periodontal disease, dental caries
- Medical subject headings
- Disease, Periodontal Diseases, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnamnesisOther
A detailed anamnesis should be carried out in order to know the habits, the presence of systemic pathologies, the use of medication
Oral clinical examinationOther
Clinical examination should be carried out evaluating the presence of caries, tooth loss, periodontal condition, occlusal factors
| Study group | Role | What they receive |
|---|---|---|
| Yanomamis | Yanomami Indians, Anamnesis and oral clinical examination Receives: Other: Anamnesis; Other: Oral clinical examination | |
| Macuxi | Macuxi Indians, Anamnesis and oral clinical examination Receives: Other: Anamnesis; Other: Oral clinical examination | |
| Wapixana | Wapixana Indians, Anamnesis and oral clinical examination Receives: Other: Anamnesis; Other: Oral clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Deep
probing deep in six points/teeth
Measured: 1 day
Secondary outcomes (2)
Gingival index
gingival index in four points / teeth
Measured: 1 day
Plaque index
plaque index in four points/teeth
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start2 Mar 2017
- Primary completion2 May 2017
- Study completion2 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnosis, OralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Metropolitana de Santos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CAIO VINICIUS GONÇALVES ROMAN TORRES, Universidade Metropolitana de Santos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660410
- Sponsor's protocol ID
- SantosMU03
- Status last verified
- Sep 2018
- First submitted
- 4 Sep 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Oral Conditions in Indigenous Populations in the State of Roraima - Brazil
- ClinicalTrials.gov ID
- NCT03660410
- Acronym / sponsor ID
- SantosMU03
- Conditions
- Diagnosis, Oral, Periodontal Diseases, Caries, Dental
- Keywords
- indians, south american, periodontal disease, dental caries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universidade Metropolitana de SantosUniversity, hospital or other
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 2 May 2017 (actual)
- Study completion
- 2 Oct 2017 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yanomamis | – | Other: Anamnesis, Other: Oral clinical examinationYanomami Indians, Anamnesis and oral clinical examination |
| Macuxi | – | Other: Anamnesis, Other: Oral clinical examinationMacuxi Indians, Anamnesis and oral clinical examination |
| Wapixana | – | Other: Anamnesis, Other: Oral clinical examinationWapixana Indians, Anamnesis and oral clinical examination |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- individuals of the Macuxi, Yanomami and Wapixana ethnic groups aged between 18 and 75 years
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnamnesisA detailed anamnesis should be carried out in order to know the habits, the presence of systemic pathologies, the use of medication | Other | Macuxi, Wapixana, Yanomamis |
| Oral clinical examinationClinical examination should be carried out evaluating the presence of caries, tooth loss, periodontal condition, occlusal factors | Other | Macuxi, Wapixana, Yanomamis |
Primary outcome
Probing Deep
Time frame: 1 day
probing deep in six points/teeth
2 secondary outcomes
Gingival index
Time frame: 1 day
Plaque index
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnosis, Oral and Periodontal Diseases, run by Universidade Metropolitana de Santos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Deep (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.