Back to results"Hyaluronan" Formulation for Type 2 Diabetic Patients With Dry Mouth
Primary Purpose
Dry Mouth, Xerostomia, Type 2 Diabetics
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HA formulation Oral Spray
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dry Mouth
Eligibility Criteria
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.
Sites / Locations
- Division of Endocrinology and Metabolism, Saint Louis University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HA formulation Oral Spray
Placebo Oral Spray
Arm Description
Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their assigned mouth spray, 2 times daily (morning and evening), using only the assigned mouth spray provided for the 4 week duration of the study.
Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their assigned mouth spray, 2 times daily (morning and evening), using only the assigned mouth spray provided for the 4 week duration of the study.
Outcomes
Primary Outcome Measures
Relief from drymouth using VAS scoring
Patients' perception of efficacy of a new mouth spray for 9 weeks in reducing the symptoms of drymouth in diabetic patients using VAS scoring
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03281486
Brief Title
"Hyaluronan" Formulation for Type 2 Diabetic Patients With Dry Mouth
Official Title
Clinical Evaluation of the Efficacy of "Hyaluronan" Formulation for Dry Mouth in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 28, 2018 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
You First Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Mouth, Xerostomia, Type 2 Diabetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HA formulation Oral Spray
Arm Type
Experimental
Arm Description
Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their assigned mouth spray, 2 times daily (morning and evening), using only the assigned mouth spray provided for the 4 week duration of the study.
Arm Title
Placebo Oral Spray
Arm Type
Placebo Comparator
Arm Description
Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their assigned mouth spray, 2 times daily (morning and evening), using only the assigned mouth spray provided for the 4 week duration of the study.
Intervention Type
Device
Intervention Name(s)
HA formulation Oral Spray
Intervention Description
It is an HA formulation of FDA listed ingredients
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Placebo formulation without the active ingredients
Primary Outcome Measure Information:
Title
Relief from drymouth using VAS scoring
Description
Patients' perception of efficacy of a new mouth spray for 9 weeks in reducing the symptoms of drymouth in diabetic patients using VAS scoring
Time Frame
9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Division of Endocrinology and Metabolism, Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
"Hyaluronan" Formulation for Type 2 Diabetic Patients With Dry Mouth
We'll reach out to this number within 24 hrs