Global Behavior and Periodontal Disease in Down's Syndrome Patients

NCT02941887 | Completed DMC

• 1 other identifier: FOBDownSyndrome2
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed at correlating global behavior of Down's Syndrome patients to periodontal disease status.

Conditions

Behavior; Periodontal Diseases

Keywords

Social behavior; Gingivitis; Periodontitis; Down's Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Down's Syndrome

Behavior analysis in Down's Syndrome patients

Behavioral: Behavior Analysis

Interventions

Behavior Analysis BEHAVIORAL

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

Down's Syndrome

Eligibility Criteria

• Age: 15 Years - 52 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with a medical diagnose of Down's Syndrome

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Bauru School of Dentistry

Bauru, São Paulo, 17012-901, Brazil

Location

Related Publications (1)

• 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.

  PMID: 27153191 BACKGROUND

MeSH Terms

Conditions

Behavior; Periodontal Diseases; Social Behavior; Gingivitis; Periodontitis; Down Syndrome

Interventions

Applied Behavior Analysis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 21, 2016
• Study Start: October 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 24, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)