Efficacy of Manuka Honey Oral Rinse in Treatment of Xerostomia

NCT06240806 | Completed DMC

• 1 other identifier: 23-061
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Mouth; Salivary Gland Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes in objective dry mouth score

  one month

• Increase in Unstimulated Salivary flow rate (ml/min)

  one month

• Changes in salivary potential of hydrogen ion (pH)

  one month

Study Arms (2)

Manuka honey interventional arm

ACTIVE COMPARATOR

Manuka honey used as mouth rinse in treatment of xerostomia

Other: Manuka Honey

Saline mouthwash control group

PLACEBO COMPARATOR

Saline used as mouth rinse for xerostomia

Other: Saline mouthwash

Interventions

Manuka Honey OTHER

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

Manuka honey interventional arm

Saline mouthwash OTHER

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

Saline mouthwash control group

Eligibility Criteria

• Age: 66 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \- Both genders, aged above 65 years.
• All patients must have complaint of xerostomia.
• Patients must be able to make reliable decision or communications.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

The British University in Egypt

Cairo, 3753450, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40410721 DERIVED

MeSH Terms

Conditions

Xerostomia; Salivary Gland Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients in both groups were assigned using a random number table, and then we placed the participants in 2 groups receiving mouthwashes A (Manuka honey) or B (saline oral rinse) based on the randomized list. The researcher, patients, and the statistical analyst were all unaware of which code belonged to which mouthwash and just one non-beneficiary person was aware of the contents of the bottles who revealed them after completing all the statistical analyses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: February 5, 2024
• Study Start: December 1, 2023
• Primary Completion: December 15, 2023
• Study Completion: January 10, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-01

Locations

EG (1)