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Comparable Effectiveness of Novel and Commercial Saliva Substitute Gels in Dental Patients Experiencing Xerostomia: A Randomized, Double-Blind Crossover Trial

Evaluation of xerostomia and oral wetness from novel saliva substitutes in patients experiencing dry mouth symptoms

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250309006
Enrollment
36
Registered
2025-03-09
Start date
2025-07-01
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

Healthy dental patients experiencing dry mouth symptoms mouth dryness xerostomia artificial saliva

Interventions

Every participant will be applied the intervention gel (1 inch long) 4 times a day for 14 days. Baseline and post-application parameters will be assessed.,Every participant will be applied the second
Experimental Other,Active Comparator Other
novel saliva substitute,commercial saliva substitute

Sponsors

Rangsit University, Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Healthy dental patients visiting the Oral Diagnostic Science Clinic, College of Dental Medicine, Rangsit University, and 2. Experiencing dry mouth symptoms 3. Ages are over 35 years

Exclusion criteria

Exclusion criteria: Participants 1. with an actual or planned pregnancy, 2. any known allergy regarding the investigational products, 3. being on radio or chemotherapy, 4. intake of other symptom-relieving products or artificial saliva except for drinking water, 5. with current tumors or cancer Sjogren's syndrome or other salivary gland diseases, 6. being uncooperative

Design outcomes

Primary

MeasureTime frame
oral wetness 14 days Oral moisture checker (Mucus)

Secondary

MeasureTime frame
xerostomia grading 14 days Xerostomia inventory score (Thai version),xerostomia related quality of life 14 days XeQoL (Thai version),oral mucosal dryness 14 days Clinical oral dryness score,Anxiety and depression 14 days HADS (Thai version)

Countries

Thailand

Contacts

Public ContactSupanee Thanakun

College of Dental Medicine, Rangsit University

supanee.t@rsu.ac.th029972200

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026