Senses™ Oral Swabsticks clinical trial: improving dry mouth and other oral health parameters as compared to placebo and Oralieve Mouth Spray among 65–80-year-old care home residents

Efficacy of Senses™ Oral Swabstick in improving dry mouth and other oral health parameters as compared to placebo and Oralieve Mouth Spray among 65–80-year-old residents of Quantum Carehome - a randomised controlled double blinded cross over clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN29127839

Enrollment

Registered

2021-06-07

Start date

2023-11-01

Completion date

Unknown

Last updated

2023-02-06

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

Conditions

Dry mouth (xerostomia) and related oral health parameters Signs and Symptoms Dry mouth, unspecified

Interventions

The substance that we are testing in this research is called Spilanthol (Spilanthes Extract- Also commonly known as Toothache plant). We want to test the Swabsticks containing Spilanthol on people who

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Residents of Quantum Care homes 2. Between 65 to 80 years of age 3. Belonging to both the gender 4. Have complained of dry mouth in the past one month 5. No simultaneous participation in another studies.

Exclusion criteria

Exclusion criteria: 1. Participants with known hypersensitivity to ingredients in the product 2. Participant’s taking medications to increase salivary secretion in the past six months 3. Participant’s with comorbid disease of salivary gland; Participant’s with any viral/bacterial/fungal infections 4. Participants under radiotherapy

Design outcomes

Primary

Measure	Time frame
Dry mouth Score using a 100 mm Visual Analogue Scale at baseline, 7 and 14 days	—

Secondary

Measure	Time frame
1. Clinical signs of dry mouth according to recommendations of Navazesh et al. (2003). Dryness and cracking of the corners and/or the vermilion borders of the lips were scored as 0 (normal), 1 (dry vermilion border), 2 (dry, chapped and/or fissured tissue), or as 3 (angular chelitis, redness, or fissuring at the commissure) using remote diagnosis through clinical pictures and videos at baseline, 7 days and 14 days of each treatment arm 2. Plaque index and Gingival index to assess overall oral health using remote diagnosis through clinical pictures and videos at baseline, 7 days and 14 days of each treatment arm 3. Salivary pool, scored as 0 (absence of it or any of the above-mentioned symptoms), or 1 (symptoms present) at baseline, 7 days and 14 days of each treatment arm 4. Self-assessment of halitosis (hand over mouth technique) on a 5- point Likert scale at baseline, 7 days and 14 days of each treatment arm 5. Patients’ perception of overall mouthfeel using Bluestone Mouthfeel Questionnaire at baseline, 7 days and 14 days of each treatment arm 6. Xerostomia Quality of Life questionnaire 7. Tolerance using using a 100 mm Visual Analogue Scale at baseline, 7 days and 14 days of each treatment arm 8. Adverse effects, if any present -at baseline, 7 days and 14 days of each treatment arm	—

Measure

Time frame

1. Clinical signs of dry mouth according to recommendations of Navazesh et al. (2003). Dryness and cracking of the corners and/or the vermilion borders of the lips were scored as 0 (normal), 1 (dry vermilion border), 2 (dry, chapped and/or fissured tissue), or as 3 (angular chelitis, redness, or fissuring at the commissure) using remote diagnosis through clinical pictures and videos at baseline, 7 days and 14 days of each treatment arm 2. Plaque index and Gingival index to assess overall oral health using remote diagnosis through clinical pictures and videos at baseline, 7 days and 14 days of each treatment arm 3. Salivary pool, scored as 0 (absence of it or any of the above-mentioned symptoms), or 1 (symptoms present) at baseline, 7 days and 14 days of each treatment arm 4. Self-assessment of halitosis (hand over mouth technique) on a 5- point Likert scale at baseline, 7 days and 14 days of each treatment arm 5. Patients’ perception of overall mouthfeel using Bluestone Mouthfeel Questionnaire at baseline, 7 days and 14 days of each treatment arm 6. Xerostomia Quality of Life questionnaire 7. Tolerance using using a 100 mm Visual Analogue Scale at baseline, 7 days and 14 days of each treatment arm 8. Adverse effects, if any present -at baseline, 7 days and 14 days of each treatment arm

—

Countries

England, United Kingdom

Contacts

Public ContactSian Ellingworth-Hutley

sian.ellingworth@lobal.co.uk+44 (0)7557 410860

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026