Beneficial Effects of Natural Products on Management of Xerostomia

NCT06217614 | Completed DMC

• 1 other identifier: 22-018
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Xerostomia, the subjective feeling of oral dryness, is a symptom most frequently accompanied by either decreased salivary flow or an altered composition of saliva. Hyposalivation, on the other hand, is the objective measured reduction in salivary flow rate. Xerostomia is a relatively common complaint, particularly among older people, and can lead to major consequences with regard to the quality of their general and oral health and wellbeing. 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.

Conditions

Xerostomia; Diabetes Mellitus; Hypertension; Post COVID-19 Condition

Keywords

Manuka honey; Green tea; Natural products

Outcome Measures

Primary Outcomes (1)

• Changes in subjective dry mouth score

  subjective dry mouth scores were calculated as the number of asked questions about dry mouth symptoms (0-4), and patients with a score higher than 1 considered having xerostomia so higher scores more than 1 out of 4 indicating xerostomia but lower scores suggesting improvement.

  one month

Secondary Outcomes (3)

• Changes in objective dry mouth score

  one month

• Salivary flow rates

  one month

• Salivary Nitric oxide levels

  one month

Study Arms (2)

(Manuka honey-green tea) interventional arm

ACTIVE COMPARATOR

• (Manuka honey-green tea) will topically be applied to the oral mucosa as oral rinse 3 times per day to treat xerostomia.

Other: (Manuka honey-green tea)

Saline mouthwash control group

PLACEBO COMPARATOR

Patients in the control arm followed the same protocol with normal saline rinses in the same bottles 3 times per day for xerostomia

Other: (Manuka honey-green tea)

Interventions

(Manuka honey-green tea) OTHER

Manuka honey is a natural honey, and green tea are herbs Dried green tea leaves (100 gm) will be soaked into 500 ml of methanol solution for two days. Green tea plus ginger mouthwash was prepared by adding 50% green tea extract and 50% ginger extract. After extraction, the extract was filtered and taker to the vacuum evaporator to remove the solvent. The mouthwash was prepared by adding 3 gm of each extract, 0.12 gm sodium saccharin, and one liter distilled water, then every 20 ml of Manuka honey were added in 100 ml of (green tea and ginger solution). Finally, the mixture was stirred vigorously until all the particles were dissolved. Thereafter the obtained mixture was filtered. The mouthwash then filled in sterilized amber color bottles of 250 ml each. According to similar studies performed in this field, the patients used a 20ml of (Manuka honey-green tea- ginger) mouthwash three times a day (preferably after their meals), kept it for one minute, and then poured it out

(Manuka honey-green tea) interventional arm; Saline mouthwash control group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Both genders, aged above 19 years.
• All patients must have complaint of xerostomia.
• Objective dry mouth score from (2-5).
• Subjective dry mouth score from (1-4).
• 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

MeSH Terms

Conditions

Xerostomia; Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will not know the intervention in each group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: (Manuka honey-green tea) will topically be applied to the oral mucosa as oral rinse 3 times per day. Patients will be instructed not to swallow (Manuka honey-green tea) mouth rinse.

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 22, 2024
• Study Start: August 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

EG (1)