Efficacy of a Cordycepin-Based Toothpaste on Xerostomia, Salivary Flow Rate, and Oral Mucosal Moisture in Elderly Diabetic Patients with Hyposalivation: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260601023

Enrollment

Registered

2026-06-01

Start date

2021-12-01

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

Hyposalivation, xerostomia xerostomia

Interventions

Dose and mode of administration: Route: Topical oral application (toothbrushing) Amount: A pea-sized amount of toothpaste (approximately 1-1.5 g) per brushing session Frequency: Twice daily (morning a

Experimental Other,No Intervention Other

Cordycepin toothpaste,Standard fluoride toothpaste

Eligibility

Sex/Gender

All

Age

50 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Elderly patients aged 50 years or above with a confirmed type 2 diabetes mellitus (T2DM) diagnosis 2. Classified as having xerostomia based on the xerostomia assessment questionnaire 3. No other systemic diseases or oral conditions related to infection 4. No use of antibiotics or any mouthwash for at least two weeks prior to enrollment 5. No known allergy to cordycepin, herbal extracts, or any study product 6. Not using artificial saliva 7. No history of head or neck radiation therapy 8. Provided written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients who required antibiotic therapy during the trial period 2. Pregnant women 3. Current smokers

Design outcomes

Primary

Measure	Time frame
Unstimulated whole salivary flow rate Baseline (week 0), week 2, and week 4 post-intervention Spitting method: saliva expectorated into pre-weighed 50 mL tube over 5 minutes. Flow rate calculated as weight difference divided by collection time, expressed in mL/min.	—

Secondary

Measure	Time frame
Xerostomia severity score Baseline (week 0), week 2, and week 4 post-intervention Five-item yes/no questionnaire. Score ranges 0-5; score of 1 or above indicates xerostomia. Administered via face-to-face interview.,Oral mucosal moisture at dorsal tongue surface Baseline (week 0), week 2, and week 4 post-intervention Modified cotton method: pre-weighed sterile cotton roll placed on dorsal tongue surface for 30 seconds. Moisture expressed in grams.,Oral mucosal moisture at the hypoglossus Baseline (week 0), week 2, and week 4 post-intervention Modified cotton method: pre-weighed sterile cotton roll placed on hypoglossus for 30 seconds. Moisture expressed in grams.	—

Measure

Time frame

Xerostomia severity score Baseline (week 0), week 2, and week 4 post-intervention Five-item yes/no questionnaire. Score ranges 0-5; score of 1 or above indicates xerostomia. Administered via face-to-face interview.,Oral mucosal moisture at dorsal tongue surface Baseline (week 0), week 2, and week 4 post-intervention Modified cotton method: pre-weighed sterile cotton roll placed on dorsal tongue surface for 30 seconds. Moisture expressed in grams.,Oral mucosal moisture at the hypoglossus Baseline (week 0), week 2, and week 4 post-intervention Modified cotton method: pre-weighed sterile cotton roll placed on hypoglossus for 30 seconds. Moisture expressed in grams.

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Countries

Thailand

Contacts

Public ContactKrispijyakorn Sangharn

Suranaree University of Technology

krispijyakorn@g.sut.ac.th6644223582

Outcome results

None listed

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