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临床试验/NCT05481567
NCT05481567Unknown不适用

Oral Health Related Quality of Life in Patients Affected by Periodontitis Stage III and IV: a Survey Based on OHIP14 Questionnaire

University of Cagliari1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Overall score

研究概览

简要总结

Patients diagnosed with stage III or IV periodontitis during routine visits at the department of periodontology will undergo a validated questionnaire to understand the impact of the disease on their quality of life.

详细描述

The purpose of this study is to evaluate the impact of stage III and stage IV periodontitis on the quality of life of patients and to evaluate the differences of the results between the two forms of the disease.

Patients who presents to our periodontology department for routine follow-up visits, if diagnosed with one of these two forms of periodontitis, will be asked if they intend to answer a short questionnaire with the intent to understand how the disease affects their daily activities and interactions.

The questionnaire that will be used is the short-form Oral Health Impact Profile (OHIP-14), which consists of 14 questions each one formulated in the following way: "How often (impact item) because of problems with your teeth, mouth, or dentures?" The impact items belong to seven different impact domains: (a) functional limitations, (b) physical pain, (c) psychological discomfort, (d) physical disability, (e) psychological disability, (f) social disability, and (g) handicap. Each question could be answered with a score from 0 to 4 corresponding to: 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, and 4 = very often.

The impact items are:

Had trouble in pronouncing words Felt that sense of taste had worsened Had painful aching in your mouth Found it uncomfortable when eating food Been feeling self-conscious Have you felt tense Diet has been unsatisfactory Had to interrupt meals Found it difficult to relax Been a bit embarrassed Been irritable with other people Had difficulty during usual jobs Felt that life less satisfying Been totally unable to function Overall mean scores as well as for each question and for each impact domain will be calculated and compared with two ways ANOVA statistical analysis.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients affected by periodontitis stage III
  • Patients affected by periodontitis stage IV

排除标准

  • Patients affected by periodontitis stage I
  • Patients affected by periodontitis stage II

结局指标

主要结局

Overall score

时间窗: 1 day (At the time of evaluation, the first time the patients is evaluated and diagnosed with either periodontitis stage III or stage IV)

The sum of the scores of each of the seven impact domains of the Oral Health Impact Profile OHIP14 survey (0 = never to 4 = very often)

次要结局

  • Impact domain score(1 day (At the time of evaluation, the first time the patients is evaluated and diagnosed with either periodontitis stage III or stage IV))

研究者

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

Nicola Alberto Valente, DDS, MS, PhD

Assistant Professor

University of Cagliari

研究点 (1)

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