Clinical Study New Gel for Xerostomia

Overview

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.

Full Title of Study: “Clinical Study to Evaluate the Efectiveness and Tolerability of a New Gel for Xerostomia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2, 2019

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 90 Years

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • Universidad de Murcia
    • Provider of Information About this Clinical Study
      • Principal Investigator: Pia Lopez Jornet, UNIVERSIDAD DE MURCIA – Universidad de Murcia
    • Overall Contact(s)
      • Pia López-Jornet, PhD, 639473308, majornet@um.es

    References

    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.

    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.

    Łysik 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.

    Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

    At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.