Clinical Study New Gel for Xerostomia

Last updated: December 3, 2019
Sponsor: Universidad de Murcia
Overall Status: Active - Recruiting

Phase

1

Condition

Dry Mouth

Saliva And Salivary Gland Dysfunction

Treatment

N/A

Clinical Study ID

NCT04184908
UNIVERSITY
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects of both sexes 2. Over 18 years. 3. Adequate cultural level and understanding of the clinical study. 4. Agree to voluntarily participate in the study and give their informed consent in writing 5. Present xerostomia of more than three months of evolution / sialometry less than 0.2ml / 5 min.

Exclusion criteria

The presence of at least one of the following criteria will be grounds for exclusion from the clinical trial:

  1. Presence of health problems that may compromise adherence to the study protocol.

  2. Pregnant or breastfeeding women.

  3. Present hypersensitivity to any component of the product under study.

Study Design

Total Participants: 60
Study Start date:
October 01, 2019
Estimated Completion Date:
December 31, 2020

Study 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.

Connect with a study center

  • Lopez-Jornet Pia

    Murcia, N/A = Not Applicable 30008
    Spain

    Site Not Available

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