Assessing the effectiveness of salivary gland massage on oral dryness and its impact on oral frailty and OHRQoL – A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- salivary flow rate, oral health related quality of life and oral frailty
研究概览
简要总结
This parallel randomized controlled trial aims to evaluate the efficacy of daily salivary gland massage in mitigating oral dryness and its subsequent impact on oral frailty and oral health-related quality of life among institutionalized elderly individuals. The study addresses the high prevalence of xerostomia in the geriatric population, which contributes to functional decline and nutritional issues, by proposing a low-cost, non-pharmacological intervention. the research will involve aged 60 and above institutionalized individuals who have self-reported oral dryness. These participants will be randomly allocated into two groups: an intervention group performing daily salivary gland massage alongside oral hygiene instructions, and a control group receiving only oral hygiene instructions. Over a one-month duration, the study will track the primary outcome of salivary flow rate using the Oral Schirmer’s test, alongside secondary outcomes including oral frailty (OFI-8), and oral health related quality of life (GOHAI), with data collected at baseline, 15 days, and 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •Elderly Participants of aged 60 years and above (both males and females) with self reported oral dryness and who are able to understand the study procedures and able to tolerate gentle massage of facial and jaw region were included.
排除标准
- 未提供
结局指标
主要结局
salivary flow rate, oral health related quality of life and oral frailty
时间窗: salivary flow rate
次要结局
- oral health related quality of life and oral frailty(base line, after 15 days and after 30 days)
研究者
Saranya J Prakash
Chettinad dental college and research institute
