Efficacy of Manuka Honey Oral Rinse in Treatment of Xerostomia

NCT ID: NCT06240806

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-01-10

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.

Conditions

Dry Mouth; Salivary Gland Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Manuka honey interventional arm

Manuka honey used as mouth rinse in treatment of xerostomia

Group Type: ACTIVE_COMPARATOR

Manuka Honey

Intervention Type: OTHER

Manuka honey will be topically applied to the oral mucosa as oral rinse based on the Biswal et al., 2003 administration protocol.

Saline mouthwash control group

Saline used as mouth rinse for xerostomia

Group Type: PLACEBO_COMPARATOR

Saline mouthwash

Intervention Type: OTHER

Saline mouthwash will be used 3 times per day for one month

Interventions

Manuka Honey

Manuka honey will be topically applied to the oral mucosa as oral rinse based on the Biswal et al., 2003 administration protocol.

Intervention Type: OTHER

Saline mouthwash

Saline mouthwash will be used 3 times per day for one month

Intervention Type: OTHER

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.

• Minimum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

British University In Egypt

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The British University in Egypt

Cairo, , Egypt

Countries

Egypt

References

Ghalwash D, El-Gawish A, Abou-Bakr A. Efficacy of Manuka honey oral rinse in treatment of xerostomia among elderly patients: a randomized controlled trial. BMC Oral Health. 2025 May 23;25(1):777. doi: 10.1186/s12903-025-06125-9.

Reference Type: DERIVED

PMID: 40410721 (View on PubMed)

Other Identifiers

23-061

Identifier Type: -

Identifier Source: org_study_id