NCT05885906

Aloe Vera Versus Thyme Honey Mouthwash in Management of Xerostomia in Type 2 Diabetics

Aloe Vera Versus Thyme Honey Mouthwash in Management of Xerostomia in Type 2 Diabetics (A Randomized Controlled Clinical Trial With Biochemical Analysis)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The objectives of the present study are to: 1. Compare the clinical efficacy of (50%) aloe vera versus (20%) thyme honey mouthwash on management of xerostomia in diabetic patients by measuring the salivary flow rate as a primary objective. 2. Asses the biochemical effect of aloe vera and thyme honey on the level of salivary nitric oxide, xerostomia grade as well as patient quality of life as a secondary objective. Research question: Which is better aloe vera or thyme honey in improving salivary flow rate in diabetic patients suffering from xerostomia? Patient Grouping and Randomization: Patients with xerostomia will be randomly distributed into three groups using a computer-generated randomization table. Allocation concealment will be achieved by a sealed opaque envelope with a ratio of 1:1:1 Group 1 (Aloe Vera group) Include (15) patient suffering from diabetes induced xerostomia that will receive aloe vera as mouthwash Group 2 (Thyme honey group): Include (15) patient suffering from diabetes induced xerostomia that will receive thyme honey mouthwash Group 3 (Saline control group): Include (15) patient suffering from diabetes induced xerostomia that will receive saline mouthwash

Detailed description

Saliva is a complex mix from major as well as minor salivary glands and gingival crevicular fluids. It is a clear and slightly acidic diluted secretion with more than 99% water, electrolytes, immunoglobulins, enzymes, proteins, mucin and nitrogenous products. Subjective feeling of a dry mouth is known as xerostomia, which may result from diminished saliva production, but some people reported feeling a dry mouth even though there was no decrease in saliva quantity.Diabetes mellitus is considered one of the main causes of xerostomia There are different treatments modalities of xerostomia which include pharmacological and non-pharmacological treatments.Recently different herbs were used in the treatment of xerostomia and showed promising results and great patient acceptance among which aloe vera and thyme honey are used.

Conditions

• Xerostomia

Interventions

Type	Name	Description
DRUG	Aloevera	Mouthwash
DRUG	Thyme honey	Mouthwash
DRUG	Saline	Mouthwash

Timeline

• Start date: 2023-07-24
• Primary completion: 2023-10-01
• Completion: 2024-03-01
• First posted: 2023-06-02
• Last updated: 2023-09-14

Locations

1 site across 1 country: Egypt