Clinical Study New Gel for Xerostomia

XEROSTOMIA Clinical Trial

— XEROSTOMIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04184908
• Other study ID #: UNIVERSITY
• Status: Recruiting
• Phase: Phase 1
• Start date: October 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2019
• Source: Universidad de Murcia
• Contact: Pia López-Jornet, PhD
• Phone: 639473308
• Email: majornet[@]um.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: November 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• XEROSTOMIA

Intervention

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:
• 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

Locations

Country	Name	City	State
Spain	Lopez-Jornet Pia	Murcia	N/A = Not Applicable
Spain	Lopez-Jornet Pia	Murcia	N/A = Not Applicable

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. Review. — View 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. Review. — View 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). pii: E3199. doi: 10.3390/ijms20133199. Review. — View Citation

Outcome

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