BehaviorNCT02941887
Global Behavior and Periodontal Disease in Down's Syndrome Patients
An observational study of Behavior and Periodontal Diseases, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study aimed at correlating global behavior of Down's Syndrome patients to periodontal disease status. Read more about this study
- Who is it for?
- Ages 15 to 52 years
- Conditions the study is for
- Behavior, Periodontal Diseases
- What is being tested?
- Behavior Analysis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2013to Oct 2016
- 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 15 to 52 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with a medical diagnose of Down's Syndrome
Who may be able to join
- Down's Syndrome Diagnose characterized by the whole chromosomal aneuploidy 15 to 52 years
- Absence of severe hearing loss could impair the comprehension about the dental treatment
- Absence of severe visual loss that could impair the comprehension about the dental treatment
- Presence of at least four teeth being one for hemiarch.
- Diagnose of gingivitis and periodontitis
- Absence of acute periodontal disease and necrotizing periodontal disease.
Who cannot join
- Smokers
- Use of alcohol
- Menopause
- Pregnancy
- Absence of all teeth
- Uncontrolled diabetes mellitus
Show all 14Show fewer
- Uncontrolled hyperthyroidism
- Angina
- Uncontrolled hypertension
- Coagulopathy
- Use of illicit drugs
- Head and neck radiotherapy
- Chemotherapy
- Non-cooperative patients or patients with other diseases as autism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Down's Syndrome Patients Behavior Correlations to Periodontal Disease Status
This study aimed at correlating global behavior of Down's Syndrome patients to periodontal disease status.
Read the detailed description
There is a higher prevalence and severity of periodontal disease in Down's Syndrome patients. Plaque levels in these patients are high due to poor hygiene habits. Behavior also may contribute to the overall periodontal condition.
- Conditions
- Behavior, Periodontal Diseases
- Being tested
- Behavior Analysis
- Keywords
- Social behavior, Gingivitis, Periodontitis, Down's Syndrome
- Medical subject headings
- Behavior, Periodontal Diseases, Social Behavior, Gingivitis, Periodontitis, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior AnalysisBehavioural
One examiner observed global behavior of patients during a dental care session, guided by a behavioral scale.
| Study group | Role | What they receive |
|---|---|---|
| Down's Syndrome | Behavior analysis in Down's Syndrome patients Receives: Behavioral: Behavior Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity
Severe periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with clinical attachment level (CAL) ≥ 6mm and ≥1 interproximal site with pocket probing depth (PPD) ≥5mm. Moderate periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with CAL ≥ 4mm or ≥ 2 interproximal sites in different teeth with PPD ≥5mm. Mild periodontitis was defined as ≥ 2 interproximal sites in different teeth with ≥ 3 mm CAL and ≥ 2 interproximal sites in different teeth with ≥ 4 mm PPD or at least 1 site with PPD ≥ 5 mm (20,21). Gingivitis was determined as follows: Subjects were considered healthy if presented PPD ≤3mm/BOP extent scores < 10% and with gingivitis if presented PPD ≤3mm/ bleeding on probing (BOP) extent scores >10%. Prevalence of periodontal disease was the sum of gingivitis, mild, moderate and severe periodontitis.
Measured: One day
Global behavior - observation and scoring based on a behavior scale
Behavioral aspects: Interaction to evaluator, Communicative intention, Attention time, Response to conversation, Comprehension of concrete/no concrete situations with/without visual support, Parental interference, Acceptance of activities, Mimic, Eye contact, Participation in the dialogue (speech), Logical time sequence, Dialogue keeping, Word production
Scores: 0 - absence, 1 - strictly presented, 2 - evidently presented.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startOct 2013
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BehaviorStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Carla Andreotti Damante, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941887
- Sponsor's protocol ID
- FOBDownSyndrome2
- Status last verified
- Oct 2016
- First submitted
- 19 Oct 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Startin CM, Rodger E, Fodor-Wynne L, Hamburg S, Strydom A. Developing an Informant Questionnaire for Cognitive Abilities in Down Syndrome: The Cognitive Scale for Down Syndrome (CS-DS). PLoS One. 2016 May 6;11(5):e0154596. doi: 10.1371/journal.pone.0154596. eCollection 2016.
PubMed 27153191
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Down's Syndrome Patients Behavior Correlations to Periodontal Disease Status
- ClinicalTrials.gov ID
- NCT02941887
- Acronym / sponsor ID
- FOBDownSyndrome2
- Conditions
- Behavior, Periodontal Diseases
- Keywords
- Social behavior, Gingivitis, Periodontitis, Down's Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Oct 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 21 Oct 2016 (estimated)
- 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.
This study aimed at correlating global behavior of Down's Syndrome patients to periodontal disease status.
Detailed description
There is a higher prevalence and severity of periodontal disease in Down's Syndrome patients. Plaque levels in these patients are high due to poor hygiene habits. Behavior also may contribute to the overall periodontal condition.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Down's Syndrome | – | Behavioral: Behavior AnalysisBehavior analysis in Down's Syndrome patients |
Who may qualify
- Ages
- 15 to 52 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with a medical diagnose of Down's Syndrome
Key inclusion criteria (6 listed)
- Down's Syndrome Diagnose characterized by the whole chromosomal aneuploidy 15 to 52 years
- Absence of severe hearing loss could impair the comprehension about the dental treatment
- Absence of severe visual loss that could impair the comprehension about the dental treatment
- Presence of at least four teeth being one for hemiarch.
- Diagnose of gingivitis and periodontitis
Key exclusion criteria (14 listed)
- Smokers
- Use of alcohol
- Menopause
- Pregnancy
- Absence of all teeth
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 |
|---|---|---|
| Behavior AnalysisOne examiner observed global behavior of patients during a dental care session, guided by a behavioral scale. | Behavioural | Down's Syndrome |
Primary outcome
Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity
Time frame: One day
Severe periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with clinical attachment level (CAL) ≥ 6mm and ≥1 interproximal site with pocket probing depth (PPD) ≥5mm. Moderate periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with CAL ≥ 4mm or ≥ 2 interproximal sites in different teeth with PPD ≥5mm. Mild periodontitis was defined as ≥ 2 interproximal sites in different teeth with ≥ 3 mm CAL and ≥ 2 interproximal sites in different teeth with ≥ 4 mm PPD or at least 1 site with PPD ≥ 5 mm (20,21). Gingivitis was determined as follows: Subjects were considered healthy if presented PPD ≤3mm/BOP extent scores < 10% and with gingivitis if presented PPD ≤3mm/ bleeding on probing (BOP) extent scores >10%. Prevalence of periodontal disease was the sum of gingivitis, mild, moderate and severe periodontitis.
Global behavior - observation and scoring based on a behavior scale
Time frame: One day
Behavioral aspects: Interaction to evaluator, Communicative intention, Attention time, Response to conversation, Comprehension of concrete/no concrete situations with/without visual support, Parental interference, Acceptance of activities, Mimic, Eye contact, Participation in the dialogue (speech), Logical time sequence, Dialogue keeping, Word production Scores: 0 - absence, 1 - strictly presented, 2 - evidently presented.
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 24 Oct 2016.
- Background: PubMed 27153191Startin CM, Rodger E, Fodor-Wynne L, Hamburg S, Strydom A. Developing an Informant Questionnaire for Cognitive Abilities in Down Syndrome: The Cognitive Scale for Down Syndrome (CS-DS). PLoS One. 2016 May 6;11(5):e0154596. doi: 10.1371/journal.pone.0154596. eCollection 2016.
- 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 Behavior and Periodontal Diseases, run by University of Sao Paulo 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 6 inclusion and 14 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 24 Oct 2016. 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?
Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity (time frame: One day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02941887, which also lists 1 linked publication.
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 24 Oct 2016.