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Global Behavior and Periodontal Disease in Down's Syndrome Patients

Down's Syndrome Patients Behavior Correlations to Periodontal Disease Status

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02941887
Enrollment
33
Registered
2016-10-21
Start date
2013-10-31
Completion date
2016-10-31
Last updated
2016-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior, Periodontal Diseases

Keywords

Social behavior, Gingivitis, Periodontitis, Down's Syndrome

Brief summary

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.

Interventions

BEHAVIORALBehavior Analysis

One examiner observed global behavior of patients during a dental care session, guided by a behavioral scale.

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
University of Sao Paulo
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
15 Years to 52 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Smokers * Use of alcohol * Menopause * Pregnancy * Absence of all teeth * Uncontrolled diabetes mellitus * 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.

Design outcomes

Primary

MeasureTime frameDescription
Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severityOne daySevere 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 scaleOne dayBehavioral 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026