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Completed

NCT Number: NCT03281486

"Hyaluronan" Formulation for Type 2 Diabetic Patients With Dry Mouth

An increased incidence of dental caries in association with poorly controlled diabetes has also been reported, Xerostomia (dry mouth) has been reported to be a common complaint of patients with diabetes, Without adequate saliva production, both hard and soft tissues of the mouth can be severely damaged and become more susceptible to infections. This 9 week, cross-over group, randomized, single center, study will evaluate the efficacy of HA formulation in alleviating dry mouth in type 2 diabetic patients.

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Key information

Conditions

Dry Mouth Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases Type 2 Diabetics Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Endocrinology and Metabolism, Saint Louis University

St Louis, Missouri, 63104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient should be above 18 years of age.
  • Patients who have been diagnosed with type 2 diabetes and have developed dry mouth or have worsening of pre-existing dry mouth condition.
  • Ability to attend visits at the research site
  • Patient should be able to read and/or understand and sign the consent form and be willing to participate in the research study
  • Agree to abstain from the use of any products for xerostomia other than those provided in the study.
  • Agree to comply with the conditions and schedule of the study.

Exclusion criteria

  • Subjects with open mouth sores at study entry.
  • Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia.
  • Subjects who are nursing, becoming pregnant or plan to become pregnant during the study period
  • Subjects currently on medication or treatment for dry mouth/xerostomia
  • Hypersensitivity to any of the following ingredients- HA ,xylitol and Sodium Benzoate.
  • Subjects with soft or hard tissue tumor of the oral cavity.
  • Presence of severe gingivitis.
  • Chronic disease with concomitant oral manifestations other than xerostomia
  • History of radiation therapy to head and neck
  • Subjects with conditions the investigator may feel will interfere with the study.

Treatment and study plan

HA formulation Oral Spray

Device

It is an HA formulation of FDA listed ingredients

PLACEBO

Device

Placebo formulation without the active ingredients

Primary outcomes

  1. Relief from drymouth using VAS scoring

    Time frame: 9 weeks

    Patients' perception of efficacy of a new mouth spray for 9 weeks in reducing the symptoms of drymouth in diabetic patients using VAS scoring

Sponsors and collaborators

Lead sponsor

You First Services

Industry

Registry information

Official study title

Clinical Evaluation of the Efficacy of "Hyaluronan" Formulation for Dry Mouth in Patients With Type 2 Diabetes

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 13, 2017
Registry last updated
Aug 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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