Clinical Study New Gel for Xerostomia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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XEROSTOMIA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

gel xerostomia

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

gel placebo

Intervention Type OTHER

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type OTHER

Other Intervention Names

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lubricant and remineralizing agents

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes