跳至主要内容
临床试验/CTRI/2024/12/077918
CTRI/2024/12/077918尚未招募不适用

Optimizing oral health in elderly residents: A cluster randomized controlled study evaluating the impact of caregiver education in old age homes of Lucknow

Sreeja Gummalla1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年1月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
oral hygiene status by Simplified Oral Hygiene Index (OHI-S) and the Turesky-Gilmore-Glickman modification of the Quigley Hein Plaque Index

研究概览

简要总结

After obtaining permission from institution managers, oral prophylaxis will be done to all participants one month before the study commencement then institutions will be randomly allocated to either the study or control group. Baseline data collection will involve assessing oral health knowledge among caregivers using a 15-item proforma, documenting the dental conditions of residents with tools like the Simplified Oral Hygiene Index (OHI-S) and the Turesky-Gilmore-Glickman modification of the Quigley Hein Plaque Index, and evaluating oral health-related quality of life using the GOHAI index, along with the Barthel Index to assess participant dependency. The study group will receive oral health education for caregivers through a video presentation at baseline, reinforced after three months, while the control group will continue with routine care for six months, receiving oral health education afterward. Follow-up data collection at six months will reassess oral health knowledge and conditions using the same indices and a follow-up questionnaire. Oral health education for caregivers in the study group will be reinforced, and the control group will receive this education at the end of six months. Final data collection will document oral health outcomes for both groups, followed by statistical analysis to compare results.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
50.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Participants will be required to reside at the institution throughout the entire six-month period.
  • Individuals must provide written informed consent, duly undersigned by either the resident or the resident’s legal representative.
  • Participants should have 10 or more natural teeth or dentures.
  • Participants who are dependent on caregivers for their care.
  • Participants must possess the cognitive and physical conditions necessary for undergoing a comprehensive oral examination.

排除标准

  • In this study, edentulous elderly residents without dentures will be excluded.
  • Individuals who do not sign informed consent will also be excluded from participation.

结局指标

主要结局

oral hygiene status by Simplified Oral Hygiene Index (OHI-S) and the Turesky-Gilmore-Glickman modification of the Quigley Hein Plaque Index

时间窗: at Baseline and 6 months

次要结局

  • oral health knowledge among caregivers using a 15-item proforma(baseline and 6th month)

研究者

发起方
Sreeja Gummalla
申办方类型
Other [self funding]
责任方
Principal Investigator
主要研究者

Sreeja Gummalla

King Georges Medical College

研究点 (1)

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