Global Behavior and Periodontal Disease in Down's Syndrome Patients

Completed

• Conditions: Behavior; Periodontal Diseases
• Interventions: Behavioral: Behavior Analysis

• Registration Number: NCT02941887
• Lead Sponsor: University of Sao Paulo

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-10
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-21
• Last Update Submitted: 2016-10-21
• Last Update Posted: 2016-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Down's Syndrome	Behavior Analysis	Behavior analysis in Down's Syndrome patients

Primary Outcome Measures

Name	Time	Method
Global behavior - observation and scoring based on a behavior scale	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.
Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity	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.

Trial Locations

Locations (1)

Bauru School of Dentistry; 🇧🇷 Bauru, Sao Paulo, Brazil