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

You First Services

Status: Completed

Conditions: Xerostomia; Type 2 Diabetics; Dry Mouth

Treatments: Device: HA formulation Oral Spray; Device: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03281486

LUD-105-17

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

HA formulation Oral Spray

Experimental group

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.

Treatment:

Device: HA formulation Oral Spray

Placebo Oral Spray

Placebo Comparator group

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.

Treatment:

Device: Placebo