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临床试验/NCT04464941
NCT04464941已完成不适用

Oral Health Promotion Program for Persons With Severe Mental Illness: A Cluster Randomized Controlled Study

Chang Bing Show Chwan Memorial Hospital0 个研究点目标入组 68 人开始时间: 2016年3月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
68
主要终点
Dental Plaque Index

研究概览

简要总结

A cluster randomized controlled study was carried out in chronic psychiatric wards of a general hospital in central Taiwan. Sixty-eight eligible male individuals admitted to 2 wards were randomly assigned to an experimental and a control group. Participants in the experimental group underwent an oral health promotion program that consisted of biweekly group education sessions, and a 12-week individual behavioral modification for oral hygiene course. The participants in the control group received usual care only. Dental plaque (measured by the Plaque Control Index) was examined by a single dentist before and after the experiment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Assessment of dental plaque was carried out by a single dentist, who was blind to group assignment.

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients admitted in chronic psychiatric wards were eligible.

排除标准

  • significant cognitive disabilities, severe hearing impairment, orthodontic appliances, an edentulous status, or a handicap when tooth-brushing

结局指标

主要结局

Dental Plaque Index

时间窗: 12-week

Plaque Control Index (PCI) developed by O'Leary et al. to score the primary outcome, plaque accumulation, on the surfaces of the teeth. The score was computed by the existence of plaque divided by all examined surfaces; a higher plaque index indicated poor oral hygiene. We calculated a person-level plaque score by averaging plaque scores for all teeth at each examination.

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

Po-Ren Teng

MD, PhD

Chang Bing Show Chwan Memorial Hospital

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