Efficacy of Thyme Honey in The Management of Oral Aphthous Ulcers

NCT06421038 | Not Yet Recruiting DMC

• 1 other identifier: 24-031
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Recurrent aphthous stomatitis (RAS) is considered the most common oral mucosal lesion, present first in childhood or adolescence. Aphthous ulcers affect up to 25% of the general population, and 3-month recurrence rates are as high as 50%, it is more common in female, also it increases by increasing age and minor aphthous ulcers are 80% of suffered patient. Due to the antimicrobial, anti-inflammatory, antifungal, and analgesic effects of Thyme honey, and the lack of evidence in the considered population, the present study aimed to assess the effect of honey on the pain relief in patients with minor RAU as a primary objective and to assess the healing effect of natural thyme honey on minor RAU, and the Oral Health Impact Profile (OHIP-14) as a secondary objectives.

Conditions

Aphthous Stomatitis (Major) (Minor); Treatment Compliance

Keywords

Oral diseases; Thyme honey; anti-inflammatory; natural products

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Visual Analog Scale (0-10) will be used to determine the intensity of pain on day 0, day 3, day 5, and day 7.

  7 days.

Secondary Outcomes (2)

• Size of ulcers (in mm)

  7 days.

• The Oral Health Impact Profile (OHIP-14) questionnaire

  7 days

Study Arms (2)

Thyme honey

EXPERIMENTAL

10 patients will be treated by thyme honey application (100% pure natural honey, applied by themselves) on their ulcers three times a day for 7 days.

Other: Thyme honey

kenalog in orabase

ACTIVE COMPARATOR

10 patients will be treated by kenalog in orabase (Triamcinolone acetonide 0.1% in oral paste 5g), three times a day for 7 days only.

Drug: Kenalog

Interventions

Thyme honey OTHER

Thyme honey is a rich monofloral honey variety formed by bees that collect nectar from thymus vulgaris flowers. thyme honey application (100% pure natural honey, applied by themselves) on their ulcers three times a day for 7 days

Thyme honey

Kenalog DRUG

kenalog in orabase (Triamcinolone acetonide 0.1% in oral paste 5g)

Also known as: kenalog in orabase

kenalog in orabase

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study involved patients who had a positive history of having similar oral mucosal ulcers for 3-4 months and ulcers for \<48 h.
• Clinically diagnosed patients with chronic aphthous stomatitis measuring ≤5 mm in size in the oral cavity and who gave written consent for participation.
• Only single ulcers were considered for the study.
• Systemically health patients.

You may not qualify if:

• The study excluded patients with a history of associated systemic disease.
• Cases of chronic aphthous stomatitis (major), lesions of herpetic form, numerous RAS lesions, and smoking.
• In addition, no consideration was given to patients with a history of hypersensitivity to honey.

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

The British University in Egypt

Cairo, Egypt

Location

Related Publications (3)

• Bang LM, Buntting C, Molan P. The effect of dilution on the rate of hydrogen peroxide production in honey and its implications for wound healing. J Altern Complement Med. 2003 Apr;9(2):267-73. doi: 10.1089/10755530360623383.

  PMID: 12804080 BACKGROUND

• Eisen D, Carrozzo M, Bagan Sebastian JV, Thongprasom K. Number V Oral lichen planus: clinical features and management. Oral Dis. 2005 Nov;11(6):338-49. doi: 10.1111/j.1601-0825.2005.01142.x.

  PMID: 16269024 BACKGROUND

• Embil JA, Stephens RG, Manuel FR. Prevalence of recurrent herpes labialis and aphthous ulcers among young adults on six continents. Can Med Assoc J. 1975 Oct 4;113(7):627-30.

  PMID: 1181018 BACKGROUND

MeSH Terms

Conditions

Stomatitis, Aphthous; Patient Compliance

Interventions

Triamcinolone Acetonide; Triamcinolone

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Dalia Ghalwash, Phd

CONTACT

01005120159; Dalia.ghalwash@bue.edu.eg

Asmaa A Ras, Phd

CONTACT

01098015060; asmaa.aboubakr@bue.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: the care provider and the outcomes assessor will not know which treatment will be given to the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Thyme honey on recurrent aphthous stomatitis

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 20, 2024
• Study Start: May 10, 2024
• Primary Completion: May 15, 2024
• Study Completion: May 30, 2024
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)