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)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Xerostomia
• Intervention / Treatment: Drug: Aloevera; Drug: Thyme honey; Drug: Saline

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry Ain Shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Both gender, with type 2 diabetes mellitus only and suffering from xerostomia.
2. Patients willing to follow all the instructions and attend all the study-associated visits.

Exclusion Criteria:

1. Patients who had received radiation therapy to the head and neck region.
2. Patients with other systemic diseases known to cause xerostomia (Sjogren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, hepatitis C virus, tuberculosis, or sarcoidosis).
3. Patients using any other medication for their dry mouth condition (pilocarpine, cevimeline) 7 days before entering into the study.
4. Patients requiring hospitalization for any medical problem during the study.
5. Known hypersensitivity to the active ingredient of the product that will be used as assessed by the medical history questionnaire.
6. Vulnerable groups such as mentally or physically handicapped individuals, pregnant females, prisoners.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aloevera group; 15 patients suffering from diabetes induced xerostomia that will receive aloe vera as mouthwash (20 ml of aloe vera 50%) 3 times per day for 4 weeks.	Drug: Aloevera; Mouthwash
Active Comparator: Thyme honey group; 15 patients suffering from diabetes induced xerostomia that will receive thyme honey mouthwash (20 ml of thyme honey diluted in 100 ml of distilled water) 3 times per day for 4 weeks.	Drug: Thyme honey; Mouthwash
Placebo Comparator: Saline group; 15 patients suffering from diabetes induced xerostomia that will receive saline mouthwash as a control group (20 ml of saline) 3 times per day for 4 weeks.	Drug: Saline; Mouthwash

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in unstimulated Salivary flow rate	Milliliters	Baseline, 2weeks and 4weeks

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Radwa Rageb, PHD, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: type 2 diabetes; Xerostomia; Aloevera; Thyme honey
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia
• Other Study ID Numbers: FDASU-RecIM122208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No