Global Behavior and Periodontal Disease in Down's Syndrome Patients

Periodontal Diseases Clinical Trial

Official title:

Down's Syndrome Patients Behavior Correlations to Periodontal Disease Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02941887
• Other study ID #: FOBDownSyndrome2
• Status: Completed
• Phase: N/A
• First received: October 19, 2016
• Last updated: October 21, 2016
• Start date: October 2013
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 52 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Behavior
• Down Syndrome
• Gingival Diseases
• Periodontal Diseases
• Syndrome

Intervention

Behavioral:
• Behavior Analysis
One examiner observed global behavior of patients during a dental care session, guided by a behavioral scale.

Locations

Country	Name	City	State
Brazil	Bauru School of Dentistry	Bauru	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No