Efficacy of hyaluronic nanogel spray in the treatment of dry mouth: A randomized crossover study

Phase 1

Completed

• Conditions: Dry mouth patients; Xerostomia, Hyposalivation, Drymouth, HA-pNIPAM, nanogel, Saliva substitute

• Registration Number: TCTR20240608007
• Lead Sponsor: Graduate school Chulalongkorn University

Brief Summary

Twenty-nine patients completed the study. After using the Hy-N and Biotene spray for 1 week, the mean unstimulated salivary flow rate increased. This difference was found to be significant between baseline and post-spray usage. The total XQ score also decreased after using Hy-N, Biotene, and placebo spray. There were significantly different from baseline.

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-05-03
• Study Start: 2024-06-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

1.The patients aged 18 years or older
2.Patients who reported feeling uncomfortable due to dry mouth
3.Ability to understand and communicate in writing or speaking

Exclusion Criteria

1. Smoker (smoke greater than or equal to 15 cigarettes/day)
2. Alcohol drinker four drinks of alcohol/day
3. Usage of drugs that stimulate saliva flow (pilocarpine and cevimeline)
4. Burning mouth syndrome patients
5. Oral infection condition
6. Refusal to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
saliva flow rate and pH of saliva 7 days after used intervention Weight of unstimulated saliva flow rate for 5 minutes.

Secondary Outcome Measures

Name	Time	Method
Xerostomia questionnaire 7 days after used intervention and 3 days washout period questionnaire