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临床试验/NCT04683016
NCT04683016已完成不适用

Disease Perception and Oral Health Impact Profile (OHIP) Before and After Non-surgical Periodontal Treatment

University of Siena1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年6月1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
120
试验地点
1
主要终点
Change in Brief Illness Perception Questionnaire (Brief IPQ) before and after non-surgical periodontal treatment

研究概览

简要总结

The presence of periodontal diseases in patients has been associated to a worsened quality of life overall. Many different indices have been proposed over time in order to evaluate patient's centred outcomes. In particular, the most thorough questionnaire proposed so far is the Oral Health Impact Profile 49 (OHIP-49), which is composed of 49 questions. Despite its validity being unquestionable, OHIP-49 was found to be too time-consuming for the clinical scenario and, therefore, its shortened 14-question version has been proposed. A more in-depth knowledge of how these parameters change before and after periodontal treatment could enable clinicians to tailor the treatment plan according to the patients' needs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients being at least 18 years old
  • Patients with a diagnosis of Periodontitis

排除标准

  • diagnosis Gingivitis
  • diagnosis of periodontal health
  • inability or unwillingness to give informed consent

结局指标

主要结局

Change in Brief Illness Perception Questionnaire (Brief IPQ) before and after non-surgical periodontal treatment

时间窗: The questionnaire will be carried out at baseline and re-evaluation (3 months after non-surgical periodontal treatment). The change in the Brief IPQ values at baseline and after 3 months will be considered as the primary outcome measure.

Brief Illness Perception Questionnaire consists of 9 questions, each one evaluated on a scale of 0 to 10 (minimum score of 0, maximum score of 90). Higher scores mean a higher patient's perception of the disease (higher scores mean worse outcome).

Change in Oral Health Impact Profile 14 before and after non-surgical periodontal treatment

时间窗: The questionnaire will be carried out at baseline and re-evaluation (3 months after non-surgical periodontal treatment). The change in the OHIP-14 values at baseline and after 3 months will be considered as the primary outcome measure.

14 questions about the impact of oral health on the quality of life; each question will be evaluated on a scale of 1 to 5 (minimum score of 0, maximum score of 70). Higher scores mean that patient's oral health impacts more significantly on their quality of life (higher scores, worse outcomes).

次要结局

  • Change in Full Mouth Bleeding Score (FMBS) before and after non-surgical periodontal treatment(FMBS will be calculated at baseline and re-evaluation (3 months after non-surgical periodontal treatment). The change in the FMBS at baseline and after 3 months will be considered as the secondary outcome measure.)

研究者

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

Nicola Discepoli

Professor

University of Siena

研究点 (1)

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