Sesame oil wafers for alleviation of dry mouth.

Development of freeze-dried sesame oil emulsion saliva substitute for post cancer treated dry mouth patients.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240326002

Enrollment

Registered

2024-03-26

Start date

2024-02-14

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-treatment xerostomia in head and neck cancer patients. Sesame oil, Saliva Substitute, Head &amp

Interventions

FD-SOESS with 15% Sesame oil,Isomalt, Xylitol, Glycerin, Water, Natural and Artificial Flavors, Sucralose, FD&amp

C Blue

Experimental Drug,Experimental Drug

FD-SOESS,Dry mouth lozenges (Act)

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with stable head and neck post-cancer treatment. 2. Adults aged 20 years or older. 3. Patients with common comorbidities that cancer patients frequently experience, such as hypertension or diabetes and not the participants with very serious illness. 4. Participants must be consenting adults.

Exclusion criteria

Exclusion criteria: 1. Participant with no or mild dry mouth (subjective dryness score 7). 2. Participant who is allergic to sesame oil, xanthan gum, (salad dressings, bakery products, ice creams) or sodium caseinate (protein powder, coffee creamer, cheese, ice cream). 3. Participant who is taking other treatment for dry mouth. 4. Participant who cannot tolerate a dental examination. 5. Dementia patients 6. Not a bedridden patient and/or No tracheostomy

Design outcomes

Primary

Measure	Time frame
Subjective dry mouth Baseline, 2 weeks after using intervention, 2 weeks after washout period, and again 2 weeks after using control. Shortening Xerostomia Inventory,Objective dry mouth Baseline, 2 weeks after using intervention, 2 weeks after washout period, and again 2 weeks after using control. The Challacombe scale,Satisfaction levels 2 weeks VAS	—

Secondary

Measure	Time frame
Oral mucositis Baseline, 2 weeks after using intervention, 2 weeks after washout period, and again 2 weeks after using control. World Health Organization (WHO) oral mucositis scale/common toxicity scale,Dysphagia - Subjective swallowing problem Baseline, 2 weeks after using intervention, 2 weeks after washout period, and again 2 weeks after using control. Eating Assessment Tool EAT-10	—

Countries

Thailand

Contacts

Public ContactAngkana Thearmontree

Faculty of Dentistry, Prince of Songkla University

angkana.t@psu.ac.th074287650

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026