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
|Condition or disease||Intervention/treatment|
|Behavior Periodontal Diseases||Behavioral: Behavior Analysis|
|Study Type :||Observational|
|Actual Enrollment :||33 participants|
|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|
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.
- 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.
- 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.
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
|Bauru School of Dentistry|
|Bauru, Sao Paulo, Brazil, 17012-901|