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NCT05247008 Clinical Trial

Effectiveness of Thyme Honey in Management of Xerostomia in ESRD

Xerostomia Clinical Trial

Official title:
Effectiveness of Thyme Honey in Management of Xerostomia in Geriatric Patients With ESRD: Longitudinal Prospective Clinical Biochemical Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05247008
Other study ID # 972
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 10, 2021
Est. completion date October 10, 2021

Study information
Verified date February 2021
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The oral health of older people has warranted considerable research attention in the last two to three decades. One of the most oral conditions that have been related to the elderly patients was xerostomia. An elderly population that has a high rate of comorbid disease is likely to continue for the foreseeable future. Among these pathologies, End stage renal disease (ESRD) stands out as a common serious age-related disease. ESRD is a chronic irreversible renal failure. It is known also as chronic kidney disease (CKD) Stage 6 or CKD 6. Xerostomia is relatively common in patients having ESRD with prevalence ranging from 28% to 67%. Multiple pharmacological and non-pharmacological measures that have been tested in previous studies in order to improve xerostomia in patients with ESRD which were based on the stimulation of the salivary gland flow. A new alternative for the control of xerostomia is the use of thyme honey, which is a propolis gel product with strong antioxidant, antibacterial, antifungal and immunomodulation effect. It is believed that the presence of honey in the oral cavity has a sialagogue effect, stimulating the salivary glands to produce more saliva, due to the high sugar concentration in honey. The purpose of the study is to determine whether the use of thyme honey as mouth rinse will help in the treatment of xerostomia in geriatric patients with end-stage renal disease (symptom management).

Description:

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Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Thyme honey
Thyme honey will topically be applied to the oral mucosa as oral rinse based on the Biswal et al. (2003) administration protocol. Based on this protocol, patients will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day.

Locations
Country Name City State
Egypt Ain Shams University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (21)

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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 intervention] The outcome measure (subjective dry mouth score) will be measured before and 2 and 4 weeks after continuous usage of thyme honey mouth rinse (for at least 5 days per week) one month
Secondary Increase in unstimulated Salivary Flow Rate (ml/min) Increase in unstimulated Salivary Flow Rate (ml/min) [ Time Frame: baseline, 2 weeks and 4 weeks after intervention ] The outcome measure will be measured before and 2 and 4 weeks after continuous usage of thyme honey mouth rinse (for at least 5 days per week) one month
Secondary Increase in salivary Nitric oxide levels (mmol/L) using clorimetric determination method Increase in salivary Nitric oxide levels (mmol/L) using clorimetric determination method [ Time Frame: baseline and 4 weeks after intervention] The outcome measure will be measured before and 4 weeks after continuous usage of thyme honey mouth rinse (for at least 5 days per week). one month
Secondary Changes in objective dry mouth score Changes in objective dry mouth score [ Time Frame: baseline, 2 weeks and 4 weeks after intervention] The outcome measure will be measured before and 2 and 4 weeks after continuous usage of thyme honey mouth rinse (for at least 5 days per week) one month
Secondary Changes in salivary Potential of Hydrogen ion (pH) Changes in salivary Potential of Hydrogen ion (pH) [ Time Frame: baseline, 2 weeks and 4 weeks after intervention ] The outcome measure will be measured before and 2 and 4 weeks after continuous usage of thyme honey mouth rinse (for at least 5 days per week) one month
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