跳至主要内容
临床试验/NCT02941887
NCT02941887已完成不适用

Down's Syndrome Patients Behavior Correlations to Periodontal Disease Status

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
1
主要终点
Global behavior - observation and scoring based on a behavior scale

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
15 Years 至 52 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Use of alcohol
  • Menopause
  • Pregnancy
  • Absence of all teeth
  • Uncontrolled diabetes mellitus
  • Uncontrolled hyperthyroidism
  • Uncontrolled hypertension
  • Coagulopathy
  • Use of illicit drugs
  • Head and neck radiotherapy
  • Chemotherapy
  • Non-cooperative patients or patients with other diseases as autism.

结局指标

主要结局

Global behavior - observation and scoring based on a behavior scale

时间窗: 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.

Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carla Andreotti Damante

Associate professor

University of Sao Paulo

研究点 (1)

Loading locations...

相似试验

Global Behavior and Periodontal Disease in Down's... | 临床试验