Global Behavior and Periodontal Disease in Down's Syndrome Patients

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Behavior
• Intervention / Treatment: Behavioral: Behavior Analysis

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 Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Bauru, Sao Paulo, Brazil, 17012-901
      • Bauru School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 52 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with a medical diagnose of Down's Syndrome

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Down's Syndrome; Behavior analysis in Down's Syndrome patients	Behavioral: Behavior Analysis; One examiner observed global behavior of patients during a dental care session, guided by a behavioral scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	One day

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: October 19, 2016
• First Submitted That Met QC Criteria: October 19, 2016
• First Posted (Estimate): October 21, 2016

Study Record Updates

• Last Update Posted (Estimate): October 24, 2016
• Last Update Submitted That Met QC Criteria: October 21, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Periodontitis; Social behavior; Gingivitis; Down's Syndrome
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Genetic Diseases, Inborn; Stomatognathic Diseases; Mouth Diseases; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Down Syndrome; Periodontal Diseases
• Other Study ID Numbers: FOBDownSyndrome2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO