Clinical Study New Gel for Xerostomia (XEROSTOMIA)

Clinical Study to Evaluate the Efectiveness and Tolerability of a New Gel for Xerostomia

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.

Study Overview

• Status: Unknown
• Conditions: XEROSTOMIA
• Intervention / Treatment: Drug: gel xerostomia; Other: gel placebo

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • N/A = Not Applicable
    • Murcia, N/A = Not Applicable, Spain, 30008
      • Recruiting
      • Lopez-Jornet Pia
      • Contact: Lopez-Jornet Pia; Phone Number: 639473308; Email: majornet@um.es
    • Murcia, N/A = Not Applicable, Spain, 30008
      • Not yet recruiting
      • Lopez-Jornet Pia
      • Contact: Lopez-Jornet Pia; Phone Number: 639473308; Email: majornet@um.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad de Murcia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): November 2, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: November 29, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: dry mouth
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia
• Other Study ID Numbers: University (Other Identifier: Kahramanmaras Sutcu Imam University, SCIENTIFIC RESEARCH PROJECTS COORDINATION UNIT)

Drug and device information, study documents

• 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