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Completed

NCT Number: NCT06217614

Beneficial Effects of Natural Products on Management of Xerostomia

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.

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Key information

Conditions

Xerostomia Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Post COVID-19 Condition Salivary Gland Diseases Stomatognathic Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The British University in Egypt

Cairo, 3753450, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

(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

Primary outcomes

  1. Changes in subjective dry mouth score

    Time frame: one month

    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.

Secondary outcomes

  1. Changes in objective dry mouth score

    Time frame: one month

    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

  2. Salivary flow rates

    Time frame: one month

    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

  3. Salivary Nitric oxide levels

    Time frame: one month

    Increasing in the salivary nitric oxide levels indicating improvment

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2024
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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