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Completed

NCT Number: NCT02941887

Global Behavior and Periodontal Disease in Down's Syndrome Patients

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

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Key information

Conditions

Behavior Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Gingival Diseases Gingivitis Infections Intellectual Disability Mouth Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Periodontal Diseases Periodontitis Social Behavior Stomatognathic Diseases

Age range

15 year–52 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bauru School of Dentistry

Bauru, São Paulo, 17012-901, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavior Analysis

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Down's Syndrome Patients Behavior Correlations to Periodontal Disease Status

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 21, 2016
Registry last updated
Oct 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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