NCT04184908

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. 1.General measures ; review and control of drugs,hydration and dietary advice:
  2. 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.
  3. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2019

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

1 month

First QC Date

November 29, 2019

Last Update Submit

December 3, 2019

Conditions

XEROSTOMIA

Keywords

dry mouth

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

GROUP EXPERIMENTAL

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

CONTROL GROUP

PLACEBO COMPARATOR

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

Interventions

gel xerostomiaDRUG

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

Also known as: lubricant and remineralizing agents
GROUP EXPERIMENTAL
gel placeboOTHER

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Presence of health problems that may compromise adherence to the study protocol.
  • Pregnant or breastfeeding women.
  • Present hypersensitivity to any component of the product under study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lopez-Jornet Pia

Murcia, N/A = Not Applicable, 30008, Spain

RECRUITING

Lopez-Jornet Pia

Murcia, N/A = Not Applicable, 30008, Spain

NOT YET RECRUITING

Related 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.

    PMID: 30923424BACKGROUND

  • 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.

    PMID: 27031061BACKGROUND

  • 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.

    PMID: 31261876BACKGROUND

MeSH Terms

Conditions

Xerostomia

Interventions

Lubricants

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Specialty Uses of ChemicalsChemical Actions and Uses

Central Study Contacts

Pia López-Jornet, PhD

CONTACT

639473308majornet@um.es

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
UNIVERSIDAD DE MURCIA

Study Record Dates

First Submitted

November 29, 2019

First Posted

December 4, 2019

Study Start

October 1, 2019

Primary Completion

November 2, 2019

Study Completion

December 31, 2020

Last Updated

December 5, 2019

Record last verified: 2019-12

Locations

ES(2)