Clinical Study New Gel for Xerostomia

Phase 1

• Conditions: XEROSTOMIA
• Interventions: Other: gel placebo; Drug: gel xerostomia

• Registration Number: NCT04184908
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2019-10-01
• Primary Completion: 2019-11-02
• Study First Submitted: 2019-11-29
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-03
• Last Update Submitted: 2019-12-03
• Study First Posted: 2019-12-04
• Last Update Posted: 2019-12-05
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTROL GROUP	gel placebo	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
GROUP EXPERIMENTAL	gel xerostomia	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

Primary Outcome Measures

Name	Time	Method
OHIP 14	1moth	Quality of oral life. minimun 0 maximum 56 points. As it gets higher, quality of life decreases
Test Thonsom xerostomy	1moth	Xerostomia Inventory. the higher the outcome, quality of life decreases
Sialometry	1moth	Drenaje

Trial Locations

Locations (1)

Lopez-Jornet Pia; 🇪🇸 Murcia, N/A = Not Applicable, Spain