NCT04184908: XEROSTOMIA

Clinical Study New Gel for Xerostomia

Status unknown Phase 1 Last updated 5 December 2019

What this trial tests

Phase 1 trial testing gel xerostomia in XEROSTOMIA in 60 participants. Status unknown.

Timeline

1 October 2019

Primary endpoint
2 November 2019

31 December 2020

Quick facts

Lead sponsor	Universidad de Murcia
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	1 October 2019
Primary completion	2 November 2019
Estimated completion	31 December 2020
Sites	2 locations across Spain

Drugs / interventions tested

• gel xerostomia — full drug profile →
• gel placebo

Conditions studied

• XEROSTOMIA — all drugs for XEROSTOMIA →

Sponsor

Universidad de Murcia — full company profile →

Who can join

Adults 18 to 90, any sex, with XEROSTOMIA. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Clinical Study on the Efficacy and Tolerability of a New Topical Gel and Toothpaste in Patients with Xerostomia: A Randomized Controlled Trial.
   López Jornet P, Hernandez L, Gomez García F, Galera Molero F, et al · · 2021 · cited 4× · PMID 34884343 · DOI 10.3390/jcm10235641