A study on the usefulness of oral mucosal massage for patients with xerostomia-Open-label randomized controlled trial-

UMIN ID: UMIN000040751

Registered date:01/07/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: xerostomia
• Date of first enrollment: 2020/07/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Oral mucosal massage group: Oral mucosal massage is performed at home three times after each meal for 8 weeks
Extraoral massage group: Extraoral massage is performed at home three times after each meal for 8 weeks

Outcome(s)

• Primary Outcome: Comparison of subjective improvement of dry mouth symptoms by visual analogue scale between two groups 8 weeks after the start of the study

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude criteria: 1. Those who have a clear cause of dry mouth and are capable of causal treatment 2. Those who have difficulty in performing extraoral massage or oral mucosal massage due to hand movement disorder due to rheumatoid arthritis or cognitive impairment 3. Those who have stomatitis at the oral mucosal massage site 4. Person who used moisturizer in oral cavity within 2 months 5. Any other person who the research director judges to be inappropriate as a research target person

Related Information

• Primary Sponsor: Gerodontology, Department of Oral Health Science, Faculty of Dental Medicine, Hokkaido University
• Source(s) of Monetary Support: Gerodontology, Department of Oral Health Science, Faculty of Dental Medicine, Hokkaido University