Evaluation of Responsiveness of Hindi Version of Oral Health Impact Profile for Periodontitis (OHIP-P-HIN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Minimal Important Difference (MID)
研究概览
简要总结
The distribution- and anchor-based methods will be used to estimate the Minimal Important Difference (MID) of the OHIP-P-HIN. Two established distribution-based approaches, the standardized effect size (ES) and standardized response mean (SRM) will be calculated. The ES is calculated by dividing the mean change scores in the OHIP-P-HIN from baseline by the standard deviation of the baseline scores. And the SRM are computed as ratios of the mean change score divided by its standard deviation. The anchor-based approach will be applied by using the global transition scale as the anchor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •patients able to understand and complete questionnaires independently
- •confirmed diagnosis of periodontitis
排除标准
- •Patients with systemic diseases such as acquired immunodeficiency syndrome or diabetes mellitus
- •pregnancy
- •required prophylactic antibiotic coverage prior to dental treatment,
- •patients with bleeding disorders
- •patients who had received non-surgical periodontal therapy within the preceding eight weeks.
研究组 & 干预措施
Non Surgical Periodontal Therapy
Full mouth Sub gingival instrumentation will be done
干预措施: Non Surgical Periodontal Therapy (Procedure)
结局指标
主要结局
Minimal Important Difference (MID)
时间窗: 6 weeks after completion of Non surgical Periodontal therapy
The distribution- and anchor-based methods will be used to estimate the MID. Two established distribution-based approaches, the standardized effect size (ES) and standardized response mean (SRM) will be calculated. The anchor-based approach will be applied by using the global transition scale as the anchor.
次要结局
未报告次要终点