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Trial record 1 of 764 for:    dry mouth
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Clinical Study New Gel for Xerostomia (XEROSTOMIA)

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ClinicalTrials.gov Identifier: NCT04184908
Recruitment Status : Recruiting
First Posted : December 4, 2019
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Pia Lopez Jornet, Universidad de Murcia

Brief 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.

Condition or disease Intervention/treatment Phase
XEROSTOMIA Drug: gel xerostomia Other: gel placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Efectiveness and Tolerability of a New Gel for Xerostomia
Actual Study Start Date : October 1, 2019
Actual Primary Completion Date : November 2, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

Arm Intervention/treatment
Experimental: GROUP EXPERIMENTAL
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
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 Name: lubricant and remineralizing agents

Placebo Comparator: CONTROL GROUP
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
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




Primary Outcome Measures :
  1. OHIP 14 [ Time Frame: 1moth ]
    Quality of oral life. minimun 0 maximum 56 points. As it gets higher, quality of life decreases

  2. Sialometry [ Time Frame: 1moth ]
    Drenaje

  3. Test Thonsom xerostomy [ Time Frame: 1moth ]
    Xerostomia Inventory. the higher the outcome, quality of life decreases



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04184908


Contacts
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Contact: Pia López-Jornet, PhD 639473308 majornet@um.es

Locations
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Spain
Lopez-Jornet Pia Recruiting
Murcia, N/A = Not Applicable, Spain, 30008
Contact: Lopez-Jornet Pia    639473308    majornet@um.es   
Lopez-Jornet Pia Not yet recruiting
Murcia, N/A = Not Applicable, Spain, 30008
Contact: Lopez-Jornet Pia    639473308    majornet@um.es   
Sponsors and Collaborators
Universidad de Murcia

Publications:
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Responsible Party: Pia Lopez Jornet, UNIVERSIDAD DE MURCIA, Universidad de Murcia
ClinicalTrials.gov Identifier: NCT04184908    
Other Study ID Numbers: UNIVERSITY
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Pia Lopez Jornet, Universidad de Murcia:
dry mouth
Additional relevant MeSH terms:
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Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases