Beneficial Effects of Natural Products on Management of Xerostomia

Hypertension Clinical Trial

Official title:

Beneficial Effects of Specific Natural Products on Management of Xerostomia: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06217614
• Other study ID #: 22-018
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: October 1, 2022

Study information

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

Clinical Trial 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.

Description:

Multiple pharmacological and non-pharmacological measures that have been tested in previous studies in order to improve xerostomia in patients suffering from that complaint which were based on the stimulation of the salivary gland flow. Salivary glands can be stimulated to produce saliva mechanically (for example, by chewing gum, using different formulated mouthwashes or acupressure) or through medications (such as pilocarpine, cevimeline, angiotensin-converting enzyme inhibitors and angiotensin-receptor antagonists) Overall, the available interventions do not appear to provide an effective, comprehensive and long-term management of xerostomia. This has strengthened the need for further investigation of other interventions for the management of xerostomia As Egypt is considered a low-income country, therefore, the general properties of ideal saliva substitutes to be used should be inexpensive, edible, hydrating, safe-to-swallow but retainable in the mouth.

Given the importance of the oral health status of in patients suffering from dry mouth with the associated problems, and the limited availability of proper remedy for xerostomia in the Egyptian market. This study is designed to evaluate the efficiency of different and natural treatment as a mix of (Manuka honey -green tea) mouth rinse in management of xerostomia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• - 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.

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

• Diabetes Mellitus
• Hypertension
• Xerostomia

Intervention

Other:
• (Manuka honey-green tea)
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

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	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	Changes in objective dry mouth score	Objective dry mouth scores were calculated as the number of observed dry mouth signs (0-5), and patients with a score higher than 2 having xerostomia so higher scores more than 2 out of 5 indicating xerostomia but lower scores suggesting improvement	one month
Secondary	Salivary flow rates	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 measure.; increasing in the salivary flow rate of the unstimulated saliva is considered improvment	one month
Secondary	Salivary Nitric oxide levels	Increasing in the salivary nitric oxide levels indicating improvment	one month