The Efficacy of Thyme Honey Mouth Rinse on Polypharmacy-induced Xerostomia

NCT06201923 | Completed Phase 4

• 1 other identifier: Thyme Honey Mouth Rinse
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to evaluate the clinical efficacy of thyme honey as a mouth rinse in the management of polypharmacy-induced xerostomia concerning the unstimulated whole salivary flow rate and quality of life of patients along with a biochemical assessment of salivary nitric oxide levels.

Conditions

Xerostomia

Outcome Measures

Primary Outcomes (1)

• Evaluate the clinical efficacy of 0.2% thyme honey mouth rinse on salivary flow rate of patients having polypharmacy-induced xerostomia

  To eliminate any circadian changes, the unstimulated salivary flow rate will be measured for all patients between 9:00 to 11:00 a.m. Before saliva collection, participants are requested to wait at least two hours without eating, drinking, or brushing their teeth. Then, after swallowing all the saliva present in their mouth, unstimulated whole saliva will be collected by spitting method every 60s for 5 min in a sterile tube. The tubes are kept in a refrigerator (-20 centigrade) before sending them to the laboratory to prevent changing the composition of the saliva.

  one month

Secondary Outcomes (1)

• Evaluate the clinical effect of thyme honey mouth rinse on the quality of life of the patients as well as its biochemical effect on the level of salivary nitric oxide

  one month

Study Arms (2)

Group I (Thyme H)

EXPERIMENTAL

0.2% thyme honey mouth rinse (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day.

Drug: Honey Mouthwash

Group II (Saline G)

PLACEBO COMPARATOR

normal saline oral rinse

Drug: Normal saline

Interventions

Honey Mouthwash DRUG

0.2% thyme honey mouth rinse

Also known as: thyme honey mouth rinse

Group I (Thyme H)

Normal saline DRUG

0.9% sodium chloride

Also known as: saline mouth rinse

Group II (Saline G)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both genders, aged between 40 and 65 years old.
• Patients using two or more medications known to cause xerostomia or salivary hypofunction (e.g., anxiolytics, anorexiants, anti-asthmatics, anticholinergics, anti-depressants, anti-emetics, anti-histamines, antihypertensives, anti-parkinsonians, anti-psychotics, antithrombotics, muscle relaxants, anticonvulsants, decongestants, diuretics, NSAIDs, or sedatives). Patients taking previous drugs for 240 days or more before the start of the trial and expected to continue.
• Patients are willing to follow all the instructions and attend all the study-associated visits.

You may not qualify if:

• Patients who had received radiation therapy to the head and neck region.
• Patients with other systemic diseases known to cause xerostomia (diabetes mellitus, Sjogren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, hepatitis C virus, tuberculosis, or sarcoidosis).
• Patients using any other medication for their dry mouth condition (pilocarpine, cevimeline) 7 days before entering into the study.
• Patients requiring hospitalization for any medical problem during the study.
• Known hypersensitivity to the active ingredient of the product that will be used as assessed by the medical history questionnaire.
• Vulnerable groups such as pregnant females, prisoners, and mentally or physically handicapped individuals.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of dentistry Ain Shams university

Cairo, Egypt

Location

Related Publications (14)

• Humphrey SP, Williamson RT. A review of saliva: normal composition, flow, and function. J Prosthet Dent. 2001 Feb;85(2):162-9. doi: 10.1067/mpr.2001.113778.

  PMID: 11208206 BACKGROUND

• Cassolato SF, Turnbull RS. Xerostomia: clinical aspects and treatment. Gerodontology. 2003 Dec;20(2):64-77. doi: 10.1111/j.1741-2358.2003.00064.x.

  PMID: 14697016 BACKGROUND

• Pedersen AM, Bardow A, Jensen SB, Nauntofte B. Saliva and gastrointestinal functions of taste, mastication, swallowing and digestion. Oral Dis. 2002 May;8(3):117-29. doi: 10.1034/j.1601-0825.2002.02851.x.

  PMID: 12108756 BACKGROUND

• Napenas JJ, Brennan MT, Fox PC. Diagnosis and treatment of xerostomia (dry mouth). Odontology. 2009 Jul;97(2):76-83. doi: 10.1007/s10266-008-0099-7. Epub 2009 Jul 29.

  PMID: 19639449 BACKGROUND

• Masnoon N, Shakib S, Kalisch-Ellett L, Caughey GE. What is polypharmacy? A systematic review of definitions. BMC Geriatr. 2017 Oct 10;17(1):230. doi: 10.1186/s12877-017-0621-2.

  PMID: 29017448 BACKGROUND

• Barbe AG. Medication-Induced Xerostomia and Hyposalivation in the Elderly: Culprits, Complications, and Management. Drugs Aging. 2018 Oct;35(10):877-885. doi: 10.1007/s40266-018-0588-5.

  PMID: 30187289 BACKGROUND

• Charalambous A, Lambrinou E, Katodritis N, Vomvas D, Raftopoulos V, Georgiou M, Paikousis L, Charalambous M. The effectiveness of thyme honey for the management of treatment-induced xerostomia in head and neck cancer patients: A feasibility randomized control trial. Eur J Oncol Nurs. 2017 Apr;27:1-8. doi: 10.1016/j.ejon.2017.01.001. Epub 2017 Jan 16.

  PMID: 28279391 BACKGROUND

• Charalambous M, Raftopoulos V, Paikousis L, Katodritis N, Lambrinou E, Vomvas D, Georgiou M, Charalambous A. The effect of the use of thyme honey in minimizing radiation - induced oral mucositis in head and neck cancer patients: A randomized controlled trial. Eur J Oncol Nurs. 2018 Jun;34:89-97. doi: 10.1016/j.ejon.2018.04.003. Epub 2018 Apr 30.

  PMID: 29784145 BACKGROUND

• Biswal BM, Zakaria A, Ahmad NM. Topical application of honey in the management of radiation mucositis: a preliminary study. Support Care Cancer. 2003 Apr;11(4):242-8. doi: 10.1007/s00520-003-0443-y. Epub 2003 Feb 19.

  PMID: 12673463 BACKGROUND

• Osailan SM, Pramanik R, Shirlaw P, Proctor GB, Challacombe SJ. Clinical assessment of oral dryness: development of a scoring system related to salivary flow and mucosal wetness. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Nov;114(5):597-603. doi: 10.1016/j.oooo.2012.05.009. Epub 2012 Sep 7.

  PMID: 22959491 BACKGROUND

• Ship JA, McCutcheon JA, Spivakovsky S, Kerr AR. Safety and effectiveness of topical dry mouth products containing olive oil, betaine, and xylitol in reducing xerostomia for polypharmacy-induced dry mouth. J Oral Rehabil. 2007 Oct;34(10):724-32. doi: 10.1111/j.1365-2842.2006.01718.x.

  PMID: 17824884 BACKGROUND

• Carpenter GH. The secretion, components, and properties of saliva. Annu Rev Food Sci Technol. 2013;4:267-76. doi: 10.1146/annurev-food-030212-182700.

  PMID: 23464573 BACKGROUND

• Afsaneh Abadi P, Koopaie M, Montazeri R. Comparison of salivary nitric oxide and oral health in diabetic patients with and without xerostomia. Diabetes Metab Syndr. 2020 Jan-Feb;14(1):11-15. doi: 10.1016/j.dsx.2019.11.014. Epub 2019 Nov 25.

  PMID: 31809967 BACKGROUND

• Jockel-Schneider Y, Schlagenhauf U, Stolzel P, Gossner S, Carle R, Ehmke B, Prior K, Hagenfeld D. Nitrate-rich diet alters the composition of the oral microbiota in periodontal recall patients. J Periodontol. 2021 Nov;92(11):1536-1545. doi: 10.1002/JPER.20-0778. Epub 2021 Apr 6.

  PMID: 33742692 BACKGROUND

Related Links

• The identification of inhibine, the antibacterial factor in honey, as hydrogen peroxide and its origin in a honey glucose-oxidase system
• Measuring salivary flow: Challenges and opportunities
• Subjective reports of xerostomia and objective measures of salivary gland performance

MeSH Terms

Conditions

Xerostomia

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Suzan S. Ibrahim, Prof.

  Professor of Oral Medicine, Periodontology, Faculty of Dentistry, Ain Shams University

  STUDY DIRECTOR

• Ola M. Ezzatt Hassanein, Ass. Prof.

  Associate Professor of Oral Medicine, Periodontology, Faculty of Dentistry, Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 0.2% thyme honey mouth rinse as intervention

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 11, 2024
• Study Start: January 15, 2024
• Primary Completion: November 2, 2024
• Study Completion: December 2, 2024
• Last Updated: April 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)