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Global Behavior and Periodontal Disease in Down's Syndrome Patients

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ClinicalTrials.gov Identifier: NCT02941887
Recruitment Status : Completed
First Posted : October 21, 2016
Last Update Posted : October 24, 2016
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Carla Andreotti Damante, University of Sao Paulo

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

Condition or disease Intervention/treatment
Behavior Periodontal Diseases 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.

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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Down's Syndrome Patients Behavior Correlations to Periodontal Disease Status
Study Start Date : October 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

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.




Primary Outcome Measures :
  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.




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Ages Eligible for Study:   15 Years to 52 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a medical diagnose of Down's Syndrome
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941887


Locations
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Brazil
Bauru School of Dentistry
Bauru, Sao Paulo, Brazil, 17012-901
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications:
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Responsible Party: Carla Andreotti Damante, Associate professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02941887     History of Changes
Other Study ID Numbers: FOBDownSyndrome2
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Carla Andreotti Damante, University of Sao Paulo:
Social behavior
Gingivitis
Periodontitis
Down's Syndrome
Additional relevant MeSH terms:
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Down Syndrome
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn