Clinical trial NCT06240806: Efficacy of Manuka Honey Oral Rinse in Treatment of Xerostomia
Official title: Efficacy of Manuka Honey Oral Rinse in Treatment of Xerostomia in Elderly: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Mouth
Salivary Gland Diseases
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 28
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental group will use a 20ml of (Manuka honey) in 100 ml purified water as mouthwash three times a day (preferably after their meals), kept it for one minute, and then poured it out .

the control arm followed the same protocol with normal saline rinses in the same opaque bottles 3 times per day.
Primary purpose: TREATMENT

Brief summary: Xerostomia causes many clinical problems, including oral infections, speech difficulties, and impaired chewing and swallowing of food thus may affect the individual's quality of life, therefore this study aimed to evaluate the clinical effectiveness of Manuka honey mouth rinse using the subjective dry mouth score, and patient satisfaction as primary objectives and to assess the effect of Manuka honey on the salivary flow rate, and objective dry mouth score as secondary objectives.

Detailed description: 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.

Secondary causes of xerostomia include the side-effects of radiation therapy or chemotherapy, rheumatoid arthritis, scleroderma, mixed connective tissues diseases, systemic lupus erythematous, graft versus host disease, anorexia, alcohol and smoking and commonly prescribed drugs (\>500 medications reportedly cause dry mouth). The most common medications causing hyposalivation are those with anticholinergic activity, sympathomimetic, and benzodiazepines. The risk of xerostomia increases with the synergistic effects of xerogenic medications, multiple medications, higher doses of medication, and the duration of the medication.

Honey was found to have several benefits as an alternative medicine, it has been used as a natural medicine for more than 2000 years, mainly for wound healing. Though there are many varieties of honey, only some of them e.g. Manuka honey and Malaysian Tualang honey, have been studied in detail for their medicinal properties.

Manuka honey is a monofloral honey, produced from the nectar of flowers of Manuka tree. This variety is produced from the Apis mellifera honey bees, using New Zealand Manuka plants producing specific floral-variety named as Leptospermum scoparium. The composition of Manuka honey consists of carbohydrates, minerals, proteins, fatty acids, phenolic and flavonoid compounds. Although such compounds are found in other types of honey, other unique features also occur in Manuka honey, such as an unusually high level of methylglyoxal (MGO) formed from dihydroxyacetone (DHA) which correlates with antibacterial activity.Manuka honey shows antioxidant and anticancer properties, which are considered due to its constituents-phytochemicals working as active bio-compounds.

Eligibility criteria: Inclusion Criteria:

* - Both genders, aged above 65 years.
* All patients must have complaint of xerostomia.
* 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: Increase in Unstimulated Salivary flow rate (ml/min)
timeFrame: one month
measure: Changes in salivary potential of hydrogen ion (pH)
timeFrame: one month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The British University in Egypt
Study officials:
References: