Beneficial Effects of Natural Products on Management of Xerostomia

NCT ID: NCT06217614

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2022-10-01

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

(Manuka honey-green tea) interventional arm

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

Group Type: ACTIVE_COMPARATOR

(Manuka honey-green tea)

Intervention Type: 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

Saline mouthwash control group

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

Group Type: PLACEBO_COMPARATOR

(Manuka honey-green tea)

Intervention Type: 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

Interventions

(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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

British University In Egypt

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The British University in Egypt

Cairo, , Egypt

Countries

Egypt

Other Identifiers

22-018

Identifier Type: -

Identifier Source: org_study_id