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临床试验/CTRI/2025/12/099260
CTRI/2025/12/099260招募中不适用

Assessing the effectiveness of salivary gland massage on oral dryness and its impact on oral frailty and OHRQoL – A Randomized Controlled Trial.

Saranya J Prakash1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2026年1月19日最近更新:

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

发起方
Saranya J Prakash
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Saranya J Prakash

Chettinad dental college and research institute

研究点 (1)

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