Clinical trial NCT06217614: Beneficial Effects of Natural Products on Management of Xerostomia
Official title: Beneficial Effects of Specific Natural Products on Management of Xerostomia: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerostomia
Diabetes Mellitus
Hypertension
Post COVID-19 Condition
Keywords: Manuka honey
Green tea
Natural products
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: (Manuka honey-green tea) will topically be applied to the oral mucosa as oral rinse 3 times per day.

Patients will be instructed not to swallow (Manuka honey-green tea) mouth rinse.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in subjective dry mouth score
timeFrame: one month
Secondary outcomes:
measure: Changes in objective dry mouth score
timeFrame: one month
measure: Salivary flow rates
timeFrame: one month
measure: Salivary Nitric oxide levels
timeFrame: one month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The British University in Egypt
Study officials:
References: