NCT04184908

Clinical Study New Gel for Xerostomia

Clinical Study to Evaluate the Efectiveness and Tolerability of a New Gel for Xerostomia

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Universidad de Murcia · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

At present, there is no single consensus protocol for the treatment of oral dryness, although the main objective is to improve the quality of life of patients. Current therapy for the control of xerostomia is based on the following measures: 1. General measures ; review and control of drugs,hydration and dietary advice: The main recommendations are found in the following scheme. 2. Saliva stimulants( Topics and sistemic )The option of using chewing stimuli by chewing gum with non-cariogenic sweeteners helps to improve symptoms. The investigators can also use gustatory stimuli, such as citric acid that is a potent stimulator of salivary secretion. Among the most commonly used pharmacological agents are: pilocarpine, bethanecol, civemiline 3. Saliva substitutes or artificial saliva. Saliva substitutes can provide a moisture retention layer in the oral mucosa and can be administered by liquids, spray, pills or gels. Topical treatments have few adverse effects and improve the quality of life of patients with xerostomia; In addition, they maintain oral health.

Detailed description

Randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and tolerability in patients with a non-commercialized gel and property of the promoter to treat xerostomia.

Conditions

• XEROSTOMIA

Interventions

Type	Name	Description
DRUG	gel xerostomia	Apply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night
OTHER	gel placebo	Apply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night

Timeline

• Start date: 2019-10-01
• Primary completion: 2019-11-02
• Completion: 2020-12-31
• First posted: 2019-12-04
• Last updated: 2019-12-05

Locations

2 sites across 1 country: Spain