Efficacy of Cannabidiol (CBD) for Treating Recurrent Aphthous Ulcers

Phase 2

Completed

• Conditions: cannabidiol; CBD; cannabis; RAS; recurrent aphthous ulcers; recurrent aphthous ulcer; RAU; recurrent aphthous stomatitis

• Registration Number: TCTR20220802004
• Lead Sponsor: Thailand Science Research and Innovation Fund Chulalongkorn University

Brief Summary

The present study demonstrated that CBD reduces ulcer size and accelerates ulcer healing without any local or systemic side effects. CBD exerts an anti-inflammatory effect by reducing the erythematous border size in the early stage and decreases pain intensity in the late stage of RAU. Therefore, CBD may be suitable for RAU patients who desire to avoid the use of steroid medications.

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-04-01
• Study Start: 2022-08-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

1. Willing to participate and provide informed consent, 2. Had a history of RAU (at least 2 times/year) on nonkeratinized oral mucosa, 3. Presenting with 1-3 aphthous ulcers (of less than or equal to 48 hours duration) that were 2-10 mm in diameter and easily accessible for evaluation

Exclusion Criteria

1. History of allergies to CBD, 2. Pregnancy/lactation, 3. Concurrent oral bacterial/fungal/viral infections, 4. Ulcers as a manifestation of a systemic disease such as Crohn's disease, Behcet's syndrome, or anemia, 5. Ulcers from trauma, 6. Diabetes mellitus patients, 7. Treatment with systemic steroids, oral retinoids, or other immunomodulatory agents within 1 week, 8. Treatment with nonsteroidal anti-inflammatory drugs, acetaminophen, or oral topical medications within 48 hours or during project participation, 9. History of dental surgery within 2 weeks of entering the study, 10. Orthodontic braces or retainers that might come in contact with the ulcer

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pseudomembranous ulcer size Day 0, 2, 5, and 7 Adjusted percentage area

Secondary Outcome Measures

Name	Time	Method
Erythematous border size Day 0, 2, 5, and 7 Adjusted percentage area,Pain ratings 7 days Adjusted percentage Visual Analog Scale (VAS),Subject satisfaction The last visit Satisfaction score,Quality of life The first and last visit OHIP-14 score