Beneficial Effects of Natural Products on Management of Xerostomia

British University In Egypt

Status: Completed

Conditions: Post COVID-19 Condition; Hypertension; Xerostomia; Diabetes Mellitus

Treatments: Other: (Manuka honey-green tea)

Study type: Interventional

Funder types: Other

Identifiers

NCT06217614

22-018

Details and patient eligibility

About

Xerostomia, the subjective feeling of oral dryness, is a symptom most frequently accompanied by either decreased salivary flow or an altered composition of saliva. Hyposalivation, on the other hand, is the objective measured reduction in salivary flow rate. Xerostomia is a relatively common complaint, particularly among older people, and can lead to major consequences with regard to the quality of their general and oral health and wellbeing.

Xerostomia has a variety of possible etiological factors; it is generally classified as having primary and secondary causes. Primary causes comprise conditions that directly affect the salivary glands and induce xerostomia like, Sjogren's syndrome, diabetes mellitus type 1 and 2, thyroid disease, adrenal pathology, renal or hepatic diseases, hepatitis C virus infection, and HIV disease.

Full description

Multiple pharmacological and non-pharmacological measures that have been tested in previous studies in order to improve xerostomia in patients suffering from that complaint which were based on the stimulation of the salivary gland flow. Salivary glands can be stimulated to produce saliva mechanically (for example, by chewing gum, using different formulated mouthwashes or acupressure) or through medications (such as pilocarpine, cevimeline, angiotensin-converting enzyme inhibitors and angiotensin-receptor antagonists) Overall, the available interventions do not appear to provide an effective, comprehensive and long-term management of xerostomia. This has strengthened the need for further investigation of other interventions for the management of xerostomia As Egypt is considered a low-income country, therefore, the general properties of ideal saliva substitutes to be used should be inexpensive, edible, hydrating, safe-to-swallow but retainable in the mouth.

Given the importance of the oral health status of in patients suffering from dry mouth with the associated problems, and the limited availability of proper remedy for xerostomia in the Egyptian market. This study is designed to evaluate the efficiency of different and natural treatment as a mix of (Manuka honey -green tea) mouth rinse in management of xerostomia.

Enrollment: 28 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Both genders, aged above 19 years.
• All patients must have complaint of xerostomia.
• Objective dry mouth score from (2-5).
• Subjective dry mouth score from (1-4).
• Patients must be able to make reliable decision or communications.

Exclusion criteria

• • Smoking, Alcohol.
• Patient with history of any serious illness as malignancy.
• Patients with any autoimmune disease.
• Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.
• Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups, including a placebo group

(Manuka honey-green tea) interventional arm

Active Comparator group

Description:

• (Manuka honey-green tea) will topically be applied to the oral mucosa as oral rinse 3 times per day to treat xerostomia.

Treatment:

Other: (Manuka honey-green tea)

Saline mouthwash control group

Placebo Comparator group

Description:

Patients in the control arm followed the same protocol with normal saline rinses in the same bottles 3 times per day for xerostomia

Treatment:

Other: (Manuka honey-green tea)