Clinical trial NCT04184908: Clinical Study New Gel for Xerostomia
Official title: Clinical Study to Evaluate the Efectiveness and Tolerability of a New Gel for Xerostomia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: XEROSTOMIA
Keywords: dry mouth
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: OHIP 14
timeFrame: 1moth
measure: Sialometry
timeFrame: 1moth
measure: Test Thonsom xerostomy
timeFrame: 1moth
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Lopez-Jornet Pia
state: N/A = Not Applicable
city: Murcia
country: Spain
facility: Lopez-Jornet Pia
state: N/A = Not Applicable
Study officials:
References:
citation: Assery MKA. Efficacy of Artificial Salivary Substitutes in Treatment of Xerostomia: A Systematic Review. J Pharm Bioallied Sci. 2019 Feb;11(Suppl 1):S1-S12. doi: 10.4103/jpbs.JPBS_220_18.
citation: Gil-Montoya JA, Silvestre FJ, Barrios R, Silvestre-Rangil J. Treatment of xerostomia and hyposalivation in the elderly: A systematic review. Med Oral Patol Oral Cir Bucal. 2016 May 1;21(3):e355-66. doi: 10.4317/medoral.20969.
citation: Lysik D, Niemirowicz-Laskowska K, Bucki R, Tokajuk G, Mystkowska J. Artificial Saliva: Challenges and Future Perspectives for the Treatment of Xerostomia. Int J Mol Sci. 2019 Jun 29;20(13):3199. doi: 10.3390/ijms20133199.