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

NCT ID: NCT05885906

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-24
• Study Completion Date: 2024-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Aloevera

Intervention Type: DRUG

Mouthwash

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.

Group Type: ACTIVE_COMPARATOR

Thyme honey

Intervention Type: DRUG

Mouthwash

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.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Mouthwash

Interventions

Aloevera

Mouthwash

Intervention Type: DRUG

Thyme honey

Mouthwash

Intervention Type: DRUG

Saline

Mouthwash

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Dina Borham Abdelhafez Abdellatif Elkhouly

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Radwa Rageb, PHD

Role: STUDY_DIRECTOR

Ain Shams University

Locations

Faculty of dentistry Ain shams university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FDASU-RecIM122208

Identifier Type: -

Identifier Source: org_study_id