Dry Mouth, Type 2 Diabetics, Xerostomia
Conditions
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.
Interventions
DEVICEHA formulation Oral Spray
It is an HA formulation of FDA listed ingredients
DEVICEPlacebo
Placebo formulation without the active ingredients
Sponsors
You First Services
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient should be above 18 years of age. 2. Patients who have been diagnosed with type 2 diabetes and have developed dry mouth or have worsening of pre-existing dry mouth condition. 3. Ability to attend visits at the research site 4. Patient should be able to read and/or understand and sign the consent form and be willing to participate in the research study 5. Agree to abstain from the use of any products for xerostomia other than those provided in the study. 6. Agree to comply with the conditions and schedule of the study.
Exclusion criteria
1. Subjects with open mouth sores at study entry. 2. Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia. 3. Subjects who are nursing, becoming pregnant or plan to become pregnant during the study period 4. Subjects currently on medication or treatment for dry mouth/xerostomia 5. Hypersensitivity to any of the following ingredients- HA ,xylitol and Sodium Benzoate. 6. Subjects with soft or hard tissue tumor of the oral cavity. 7. Presence of severe gingivitis. 8. Chronic disease with concomitant oral manifestations other than xerostomia 9. History of radiation therapy to head and neck 10. Subjects with conditions the investigator may feel will interfere with the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relief from drymouth using VAS scoring | 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 |
Countries
United States
Outcome results
None listed