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Clinical Study New Gel for Xerostomia

NCT04184908 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-12-05

No results posted yet for this study

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.

Conditions

  • XEROSTOMIA

Interventions

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

Sponsors & Collaborators

  • Universidad de Murcia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2019-11-02
Completion
2020-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04184908 on ClinicalTrials.gov