Efficacy of Manuka Honey Oral Rinse in Treatment of Xerostomia

Dry Mouth Clinical Trial

Official title:

Efficacy of Manuka Honey Oral Rinse in Treatment of Xerostomia in Elderly: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06240806
• Other study ID #: 23-061
• Status: Completed
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: January 10, 2024

Study information

• Verified date: January 2024
• Source: British University In Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 10, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 66 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Mouth
• Salivary Gland Diseases
• Xerostomia

Intervention

Other:
• Manuka Honey
Manuka honey will be topically applied to the oral mucosa as oral rinse based on the Biswal et al., 2003 administration protocol.
• Saline mouthwash
Saline mouthwash will be used 3 times per day for one month

Locations

Country	Name	City	State
Egypt	The British University in Egypt	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
British University In Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in subjective dry mouth score	changes in subjective dry mouth score [Time frame: baseline, 2 weeks, and 4 weeks] after manuka honey mouth rinse use higher number scores mean worse diagnosis while lower values mean better prognosis	one month
Secondary	Changes in objective dry mouth score	changes in objective dry mouth score [Time frame: baseline, 2 weeks, and 4 weeks] after manuka honey mouth rinse use higher number scores mean worse diagnosis while lower values mean better prognosis	one month
Secondary	Increase in Unstimulated Salivary flow rate (ml/min)	Eating and talking were prohibited during the time of collection. Unstimulated whole saliva was collected for 5 min by spitting method. The collection will be timed, so that flow rate (mL/min) could be measured As the salivary flow rates increased it means improvement	one month
Secondary	Changes in salivary potential of hydrogen ion (pH)	following saliva collection, pH was measured immediately using the narrow-range pH strip system (Merck). One drop of the collected saliva was placed on the test strip and its color change reflected the pH of the saliva.; As salivary pH increased it means improvement	one month